Trial Outcomes & Findings for OTR Tablet 40 mg Fasted-state Bioequivalence Study (NCT NCT03398278)
NCT ID: NCT03398278
Last Updated: 2020-01-31
Results Overview
The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
COMPLETED
PHASE1
38 participants
up to 32 hours
2020-01-31
Participant Flow
38, from Jun2017 to Oct2017, from patient database, medical clinic, advertisement recruitment and etc.
Participant milestones
| Measure |
OTR 40 Mg-OXYCONTIN 40 mg
the treatment sequence is OTR 40 mg dose first and then OXYCONTIN 40 mg dose in fasted state
|
OXYCONTIN 40 Mg-OTR 40 mg
the treatment sequence is OXYCONTIN 40 mg dose first and then OTR 40 mg dose in fasted state
|
|---|---|---|
|
Period 1
STARTED
|
19
|
19
|
|
Period 1
COMPLETED
|
18
|
19
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
18
|
19
|
|
Period 2
COMPLETED
|
16
|
17
|
|
Period 2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 subject early discontinued pre-dose because of AE
Baseline characteristics by cohort
| Measure |
OTR 40 Mg-OXYCONTIN 40 mg
n=19 Participants
the treatment sequence is OTR 40 mg dose first and then OXYCONTIN 40 mg dose
|
OXYCONTIN 40 Mg-OTR 40 mg
n=19 Participants
the treatment sequence is OXYCONTIN 40 mg dose first and then OTR 40 mg dose
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 9.61 • n=19 Participants
|
40.2 years
STANDARD_DEVIATION 10.18 • n=19 Participants
|
40.8 years
STANDARD_DEVIATION 9.79 • n=38 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=19 Participants
|
14 Participants
n=19 Participants
|
25 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=19 Participants
|
5 Participants
n=19 Participants
|
13 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
HAN
|
19 Participants
n=19 Participants
|
19 Participants
n=19 Participants
|
38 Participants
n=38 Participants
|
|
Weight
|
57.87 kg
STANDARD_DEVIATION 7.182 • n=19 Participants • 1 subject early discontinued pre-dose because of AE
|
55.19 kg
STANDARD_DEVIATION 8.088 • n=18 Participants • 1 subject early discontinued pre-dose because of AE
|
56.57 kg
STANDARD_DEVIATION 7.650 • n=37 Participants • 1 subject early discontinued pre-dose because of AE
|
|
Height
|
160.4 cm
STANDARD_DEVIATION 9.10 • n=19 Participants • 1 subject early discontinued pre-dose because of AE
|
157.7 cm
STANDARD_DEVIATION 8.21 • n=18 Participants • 1 subject early discontinued pre-dose because of AE
|
159.1 cm
STANDARD_DEVIATION 8.67 • n=37 Participants • 1 subject early discontinued pre-dose because of AE
|
|
BMI
|
22.52 kg/m2
STANDARD_DEVIATION 2.419 • n=19 Participants • 1 subject early discontinued pre-dose because of AE
|
22.16 kg/m2
STANDARD_DEVIATION 2.433 • n=18 Participants • 1 subject early discontinued pre-dose because of AE
|
22.34 kg/m2
STANDARD_DEVIATION 2.399 • n=37 Participants • 1 subject early discontinued pre-dose because of AE
|
PRIMARY outcome
Timeframe: up to 32 hoursThe analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
Outcome measures
| Measure |
Cmax of OTR 40 mg
n=32 Participants
OTR Tablet 40 mg
|
Cmax of OXYCONTIN® 40 mg
n=32 Participants
OXYCONTIN® Tablet 40 mg
|
|---|---|---|
|
Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
|
60.98 ng/mL
Interval 48.336 to 73.624
|
52.23 ng/mL
Interval 43.284 to 61.176
|
PRIMARY outcome
Timeframe: up to 32 hoursThe analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.
Outcome measures
| Measure |
Cmax of OTR 40 mg
n=32 Participants
OTR Tablet 40 mg
|
Cmax of OXYCONTIN® 40 mg
n=32 Participants
OXYCONTIN® Tablet 40 mg
|
|---|---|---|
|
AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
|
604.5095 ng*h/ml
Interval 485.26446 to 723.75454
|
588.6874 ng*h/ml
Interval 478.67315 to 698.70165
|
PRIMARY outcome
Timeframe: up to 32 hoursThe analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.
Outcome measures
| Measure |
Cmax of OTR 40 mg
n=32 Participants
OTR Tablet 40 mg
|
Cmax of OXYCONTIN® 40 mg
n=32 Participants
OXYCONTIN® Tablet 40 mg
|
|---|---|---|
|
AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
|
610.9314 ng*h/ml
Interval 488.04292 to 733.81988
|
612.8057 ng*h/ml
Interval 490.61681 to 734.99459
|
SECONDARY outcome
Timeframe: up to 35 daysAn overall summary of adverse events will be provided by treatment groups. The number and percentage of subjects reporting adverse events will be summarised by the preferred term nested within the System Organ Classification. In addition the number of reported adverse events will be summarised.
Outcome measures
| Measure |
Cmax of OTR 40 mg
n=35 Participants
OTR Tablet 40 mg
|
Cmax of OXYCONTIN® 40 mg
n=35 Participants
OXYCONTIN® Tablet 40 mg
|
|---|---|---|
|
Adverse Event of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State
Number of AEs (#)
|
23 TEAEs
|
22 TEAEs
|
|
Adverse Event of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State
Number of TEAEs (#)
|
23 TEAEs
|
22 TEAEs
|
|
Adverse Event of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State
Number of relateda TEAEs
|
15 TEAEs
|
16 TEAEs
|
SECONDARY outcome
Timeframe: up to 35 daysClinical laboratory data to be summarised includes haematology, blood chemistry, and urinalysis.Each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N) or higher than (H) the reference range for that parameter. Results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).
Outcome measures
| Measure |
Cmax of OTR 40 mg
n=35 Participants
OTR Tablet 40 mg
|
Cmax of OXYCONTIN® 40 mg
n=35 Participants
OXYCONTIN® Tablet 40 mg
|
|---|---|---|
|
Number of Lab Tests With Clinical Significance
|
3 Lab tests with clinical significance
|
3 Lab tests with clinical significance
|
SECONDARY outcome
Timeframe: up to 35 daysVital sign parameters to be summarised include systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature. Vital sign results for each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N), or higher than (H) the reference range for that parameter. Vital sign results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).
Outcome measures
| Measure |
Cmax of OTR 40 mg
n=35 Participants
OTR Tablet 40 mg
|
Cmax of OXYCONTIN® 40 mg
n=35 Participants
OXYCONTIN® Tablet 40 mg
|
|---|---|---|
|
Number of AEs Related to Vital Sign
|
2 AEs of vital signs related
|
4 AEs of vital signs related
|
SECONDARY outcome
Timeframe: up to 35 daysTwelve-lead ECG was conducted at screening and on Day 4 of Period 2.
Outcome measures
| Measure |
Cmax of OTR 40 mg
n=35 Participants
OTR Tablet 40 mg
|
Cmax of OXYCONTIN® 40 mg
n=35 Participants
OXYCONTIN® Tablet 40 mg
|
|---|---|---|
|
Number of AEs Related to ECGs
|
0 AEs of ECG related
|
0 AEs of ECG related
|
SECONDARY outcome
Timeframe: up to 35 daysPhysical examination was conducted at screening, and on Day -1, Day 4 in each Period.
Outcome measures
| Measure |
Cmax of OTR 40 mg
n=35 Participants
OTR Tablet 40 mg
|
Cmax of OXYCONTIN® 40 mg
n=35 Participants
OXYCONTIN® Tablet 40 mg
|
|---|---|---|
|
Number of AEs Related to Physical Examination
|
0 AEs related to Physical examination
|
0 AEs related to Physical examination
|
Adverse Events
OTR 40 mg
OXYCONTIN® 40 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OTR 40 mg
n=35 participants at risk
Oxycodone Tamper Resistant (OTR) Tablet 40 mg
Oxycodone Tamper Resistant: Orally taking Oxycodone Tamper Resistant 40mg in fast state
|
OXYCONTIN® 40 mg
n=35 participants at risk
OXYCONTIN® Tablet 40 mg
OXYCONTIN®: Orally taking OXYCONTIN® 40mg in fast state
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.4%
4/35 • Number of events 4 • Events will be recorded from the point at which the ICF is signed until 7±1 days after last oxycodone dose in the case of completion/discontinuation from the study. This includes new AEs that are reported within 7±1 days after last oxycodone dosing after the subject's completion/discontinuation visit.
same with clinicaltrials.gov Definitions.
|
8.6%
3/35 • Number of events 3 • Events will be recorded from the point at which the ICF is signed until 7±1 days after last oxycodone dose in the case of completion/discontinuation from the study. This includes new AEs that are reported within 7±1 days after last oxycodone dosing after the subject's completion/discontinuation visit.
same with clinicaltrials.gov Definitions.
|
|
Cardiac disorders
Diastolic blood pressure decreased
|
5.7%
2/35 • Number of events 2 • Events will be recorded from the point at which the ICF is signed until 7±1 days after last oxycodone dose in the case of completion/discontinuation from the study. This includes new AEs that are reported within 7±1 days after last oxycodone dosing after the subject's completion/discontinuation visit.
same with clinicaltrials.gov Definitions.
|
5.7%
2/35 • Number of events 2 • Events will be recorded from the point at which the ICF is signed until 7±1 days after last oxycodone dose in the case of completion/discontinuation from the study. This includes new AEs that are reported within 7±1 days after last oxycodone dosing after the subject's completion/discontinuation visit.
same with clinicaltrials.gov Definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place