Trial Outcomes & Findings for Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® (NCT NCT06492226)
NCT ID: NCT06492226
Last Updated: 2026-01-21
Results Overview
Compared the Pharmacokinetics (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Day 1 for 12 Hours
Results posted on
2026-01-21
Participant Flow
Participant milestones
| Measure |
NKF-INS(A), EU-NovoRapid, US-NovoLog
Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.
|
NKF-INS(A), US-NovoLog, EU-NovoRapid
Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 3.
|
EU-NovoRapid, NKF-INS(A), US-NovoLog
Participants first received EU-NovoRapid on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.
|
EU-NovoRapid, US-NovoLog, NKF-INS(A)
Participants first received EU-NovoRapid on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 3.
|
US-NovoLog, NKF-INS(A), EU-NovoRapid
Participants first received US-NovoLog on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 3.
|
US-NovoLog, EU-NovoRapid, NKF-INS(A)
Participants first received US-NovoLog on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 3.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
8
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
NKF-INS(A), EU-NovoRapid, US-NovoLog
Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.
|
NKF-INS(A), US-NovoLog, EU-NovoRapid
Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 3.
|
EU-NovoRapid, NKF-INS(A), US-NovoLog
Participants first received EU-NovoRapid on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.
|
EU-NovoRapid, US-NovoLog, NKF-INS(A)
Participants first received EU-NovoRapid on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 3.
|
US-NovoLog, NKF-INS(A), EU-NovoRapid
Participants first received US-NovoLog on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 3.
|
US-NovoLog, EU-NovoRapid, NKF-INS(A)
Participants first received US-NovoLog on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 3.
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®
Baseline characteristics by cohort
| Measure |
NKF-INS(A), EU-NovoRapid, US-NovoLog
n=9 Participants
Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.
|
NKF-INS(A), US-NovoLog-EU, NovoRapid
n=9 Participants
Participants first received NKF-INS(A) on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 3.
|
EU-NovoRapid, NKF-INS(A), US-NovoLog
n=9 Participants
Participants first received EU-NovoRapid on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 3.
|
EU-NovoRapid, US-NovoLog, NKF-INS(A)
n=9 Participants
Participants first received EU-NovoRapid on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received US-NovoLog on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 3.
|
US-NovoLog, NKF-INS(A), EU-NovoRapid
n=9 Participants
Participants first received US-NovoLog on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 3.
|
US-NovoLog, EU-NovoRapid, NKF-INS(A)
n=9 Participants
Participants first received US-NovoLog on Day 1 of Treatment Period 1. After a washout period of 3-14 calendar days, they then received EU-NovoRapid on Day 1 of Treatment Period 2. After an additional washout period of 5-21 calendar days, they then received NKF-INS(A) on Day 1 of Treatment Period 3.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
|
36.3 years
STANDARD_DEVIATION 6.2 • n=37 Participants
|
30.2 years
STANDARD_DEVIATION 6.3 • n=44 Participants
|
34.2 years
STANDARD_DEVIATION 9.8 • n=40 Participants
|
32.1 years
STANDARD_DEVIATION 5.7 • n=121 Participants
|
30.4 years
STANDARD_DEVIATION 8.4 • n=24 Participants
|
35.1 years
STANDARD_DEVIATION 7.8 • n=6 Participants
|
33.1 years
STANDARD_DEVIATION 7.5 • n=33 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=37 Participants
|
9 Participants
n=44 Participants
|
9 Participants
n=40 Participants
|
9 Participants
n=121 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=6 Participants
|
54 Participants
n=33 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 participants
n=37 Participants
|
9 participants
n=44 Participants
|
6 participants
n=40 Participants
|
9 participants
n=121 Participants
|
7 participants
n=24 Participants
|
6 participants
n=6 Participants
|
45 participants
n=33 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=37 Participants
|
0 participants
n=44 Participants
|
2 participants
n=40 Participants
|
0 participants
n=121 Participants
|
0 participants
n=24 Participants
|
1 participants
n=6 Participants
|
3 participants
n=33 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=37 Participants
|
0 participants
n=44 Participants
|
1 participants
n=40 Participants
|
0 participants
n=121 Participants
|
2 participants
n=24 Participants
|
2 participants
n=6 Participants
|
6 participants
n=33 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 participants
n=37 Participants
|
9 participants
n=44 Participants
|
9 participants
n=40 Participants
|
9 participants
n=121 Participants
|
9 participants
n=24 Participants
|
9 participants
n=6 Participants
|
54 participants
n=33 Participants
|
|
BMI (kg/m^2)
|
25.1 kg/m^2
STANDARD_DEVIATION 2.9 • n=37 Participants
|
24.7 kg/m^2
STANDARD_DEVIATION 2.1 • n=44 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 2.7 • n=40 Participants
|
23.9 kg/m^2
STANDARD_DEVIATION 2.1 • n=121 Participants
|
24.7 kg/m^2
STANDARD_DEVIATION 2.0 • n=24 Participants
|
23.7 kg/m^2
STANDARD_DEVIATION 2.7 • n=6 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 2.4 • n=33 Participants
|
|
Height (cm)
|
171.6 cm
STANDARD_DEVIATION 8.9 • n=37 Participants
|
172.2 cm
STANDARD_DEVIATION 7.9 • n=44 Participants
|
173.9 cm
STANDARD_DEVIATION 7.4 • n=40 Participants
|
172.6 cm
STANDARD_DEVIATION 3.9 • n=121 Participants
|
172.4 cm
STANDARD_DEVIATION 7.3 • n=24 Participants
|
171.0 cm
STANDARD_DEVIATION 9.4 • n=6 Participants
|
172.3 cm
STANDARD_DEVIATION 7.4 • n=33 Participants
|
|
Weight (kg)
|
73.9 kg
STANDARD_DEVIATION 8.8 • n=37 Participants
|
73.5 kg
STANDARD_DEVIATION 10.6 • n=44 Participants
|
73.4 kg
STANDARD_DEVIATION 10.2 • n=40 Participants
|
71.4 kg
STANDARD_DEVIATION 7.1 • n=121 Participants
|
73.6 kg
STANDARD_DEVIATION 7.7 • n=24 Participants
|
69.0 kg
STANDARD_DEVIATION 6.9 • n=6 Participants
|
72.5 kg
STANDARD_DEVIATION 8.5 • n=33 Participants
|
PRIMARY outcome
Timeframe: Day 1 for 12 HoursCompared the Pharmacokinetics (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.
Outcome measures
| Measure |
EU-NovoRapid®
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t).
|
894.971 min*ng/ml
Geometric Coefficient of Variation 18.426
|
899.163 min*ng/ml
Geometric Coefficient of Variation 18.711
|
904.131 min*ng/ml
Geometric Coefficient of Variation 17.174
|
PRIMARY outcome
Timeframe: Day 1 for 12 HoursCompared the Pharmacokinetic (PK) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart demonstrating PK similarity for insulin aspart.
Outcome measures
| Measure |
EU-NovoRapid®
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax)
|
1.754 ng/ml
Geometric Coefficient of Variation 16.331
|
1.754 ng/ml
Geometric Coefficient of Variation 17.492
|
1.805 ng/ml
Geometric Coefficient of Variation 15.255
|
PRIMARY outcome
Timeframe: Day 1 for 12 HoursCompared the Pharmacodynamic (PD) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart injection by examining Glucose Infusion Rate (GIR) profiles after a single Subcutaneous (SC) dose.
Outcome measures
| Measure |
EU-NovoRapid®
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
Area Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t).
|
166278.835 min*mg/min
Geometric Coefficient of Variation 25.467
|
167245.347 min*mg/min
Geometric Coefficient of Variation 26.287
|
171020.184 min*mg/min
Geometric Coefficient of Variation 26.779
|
PRIMARY outcome
Timeframe: Day 1 for 12 HoursCompared the Pharmacodynamic (PD) of NKF-INS(A) to United States (US)-approved and European Union (EU)-authorized insulin aspart injection by examining Glucose Infusion Rate (GIR) profiles after a single Subcutaneous (SC) dose.
Outcome measures
| Measure |
EU-NovoRapid®
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
Maximum GIR (GIRmax) of Glucose
|
604.789 mg/min
Geometric Coefficient of Variation 26.670
|
619.459 mg/min
Geometric Coefficient of Variation 29.184
|
608.934 mg/min
Geometric Coefficient of Variation 26.825
|
SECONDARY outcome
Timeframe: Day 1 for 12 HoursEvaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Outcome measures
| Measure |
EU-NovoRapid®
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞
Area Under the Insulin Aspart Concentration-Time Curve (AUC0 -4h)
|
828.375 min*ng/mL
Geometric Coefficient of Variation 19.345
|
834.396 min*ng/mL
Geometric Coefficient of Variation 20.308
|
845.061 min*ng/mL
Geometric Coefficient of Variation 17.616
|
|
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞
Area Under the Insulin Aspart Concentration-Time Curve (AUC0 -6h)
|
891.162 min*ng/mL
Geometric Coefficient of Variation 18.308
|
899.163 min*ng/mL
Geometric Coefficient of Variation 18.711
|
899.437 min*ng/mL
Geometric Coefficient of Variation 17.172
|
|
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞
Area Under the Insulin Aspart Concentration-Time Curve AUC0-12h
|
894.971 min*ng/mL
Geometric Coefficient of Variation 18.426
|
899.163 min*ng/mL
Geometric Coefficient of Variation 18.711
|
904.131 min*ng/mL
Geometric Coefficient of Variation 17.174
|
|
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve (AUC0)-4h, AUC0-6h, AUC0-12h, AUC0-∞
Area Under the Insulin Aspart Concentration-Time Curve AUC0-∞
|
965.874 min*ng/mL
Geometric Coefficient of Variation 19.327
|
988.791 min*ng/mL
Geometric Coefficient of Variation 19.146
|
959.327 min*ng/mL
Geometric Coefficient of Variation 17.480
|
SECONDARY outcome
Timeframe: Day 1 for 12 HoursEvaluated Additional Pharmacokinetic (PK) Parameters of NKF-INS(A) Compared to United States (US)-Approved and European (EU)-Authorized Insulin Aspart.
Outcome measures
| Measure |
EU-NovoRapid®
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
Time to Half-maximum Before Maximum Observed Insulin Aspart Concentration Time to Half-Maximum Before Maximum Observed Insulin Aspart Concentration (t50%-Early)
|
24.515 minutes
Geometric Coefficient of Variation 22.919
|
26.597 minutes
Geometric Coefficient of Variation 25.395
|
21.980 minutes
Geometric Coefficient of Variation 27.890
|
SECONDARY outcome
Timeframe: Day 1 for 12 HoursEvaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Outcome measures
| Measure |
EU-NovoRapid®
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
Time to Half-maximum After Maximum Observed Insulin Aspart Concentration Time to Half-Maximum After Maximum Observed Insulin Aspart Concentration (t50%-Late)
|
169.891 minutes
Geometric Coefficient of Variation 30.545
|
177.331 minutes
Geometric Coefficient of Variation 29.442
|
161.226 minutes
Geometric Coefficient of Variation 27.896
|
SECONDARY outcome
Timeframe: Day 1 for 12 HoursEvaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Outcome measures
| Measure |
EU-NovoRapid®
n=46 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=46 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=46 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
The Terminal Elimination Half-life (t1/2)
|
55.742 minutes
Geometric Coefficient of Variation 38.083
|
58.096 minutes
Geometric Coefficient of Variation 47.795
|
53.348 minutes
Geometric Coefficient of Variation 33.361
|
SECONDARY outcome
Timeframe: Day 1 for 12 HoursEvaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Outcome measures
| Measure |
EU-NovoRapid®
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=52 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve to Maximum Insulin Aspart Concentration (Tmax)
|
64.411 minutes
Geometric Coefficient of Variation 37.344
|
69.888 minutes
Geometric Coefficient of Variation 37.380
|
53.904 minutes
Geometric Coefficient of Variation 34.668
|
SECONDARY outcome
Timeframe: Day 1 for 12 HoursPopulation: The Pharmacokinetic Parameter for the 6-12 hour interval \[(6-Inf(hrs): AUC0-t(min\*ng/ml)\] only contains two participants due to only two participants recording an Aspart concentration above the lower limit of quantification beyond 6 hours. All other participants did not record a quantifiable concentration between 6 and 12 hours. Therefore, this PK parameter was not included in the bioequivilance assessment
Evaluated additional Pharmacokinetic (PK) parameters of NKF-INS(A) compared to United Stated (US)-approved and European Union (EU)-authorized insulin aspart.
Outcome measures
| Measure |
EU-NovoRapid®
n=1 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
n=1 Participants
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
NKF-INS(A)
Participants received a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment Period 3
|
|---|---|---|---|
|
PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve AUC6-12h
|
36.36 min*ng/ml
Geometric Coefficient of Variation NA
Only 2 participants recorded an Aspart concentration above the lower limit of quantification beyond 6 hours. The measure of dispersion/precision is not available as standard deviation is not calculable for 1 participant. All other participants did not record a quantifiable concentration between 6 and 12 hours. Therefore, this PK parameter was not included in the bioequivilance assessment.
|
30.360 min*ng/ml
Geometric Coefficient of Variation NA
Only 2 participants recorded an Aspart concentration above the lower limit of quantification beyond 6 hours. The measure of dispersion/precision is not available as standard deviation is not calculable for 1 participant. All other participants did not record a quantifiable concentration between 6 and 12 hours. Therefore, this PK parameter was not included in the bioequivilance assessment.
|
—
|
Adverse Events
NKF-INS(A)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
EU-NovoRapid®
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
US-NovoLog®
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NKF-INS(A)
n=53 participants at risk
Single subcutaneous dose administration over three treatment periods
NKF-INS(A): Single subcutaneous dose of 0.3 U/kg administration over three treatment periods
|
EU-NovoRapid®
n=53 participants at risk
Single subcutaneous dose administration over three treatment periods
EU-NovoRapid®: Single subcutaneous dose of 0.3 U/kg administration over three treatment periods
|
US-NovoLog®
n=52 participants at risk
Single subcutaneous dose administration over three treatment periods
US-NovoLog®: Single subcutaneous dose of 0.3 U/kg administration over three treatment periods
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
5.7%
3/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
5.8%
3/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
3.8%
2/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
Vascular disorders
Haematoma
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
General disorders
Peripheral swelling
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
General disorders
Infusion site pain
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
Musculoskeletal and connective tissue disorders
Shoulder girdle pain
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
1.9%
1/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/53 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
0.00%
0/52 • Beginning of study treatment (Day 1) until the End of Study Visit (within 2-11 days of last administration of study drug). Adverse event (AE) assessments (including injection site reactions), clinical laboratory investigations (hematology, clinical chemistry [including glucose], coagulation, and urinalysis), vital signs, physical examinations, 12-lead electrocardiogram (ECG), prior and concomitant medication assessments
Three insulin products (NKF-INS(A), EU-NovoRapid, and US-NovoLog) were administered over three treatment periods. Participants were randomized to one of six treatment sequences in a 1:1:1:1:1:1 ratio, receiving a single SC dose of 0.3 international units (IU)/kg administration of one of the three study drugs on each dosing day. All enrolled participants who completed the study received each of the 3 treatments over their 3 treatment periods
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place