Trial Outcomes & Findings for 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting (NCT NCT00834587)
NCT ID: NCT00834587
Last Updated: 2009-09-15
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Blood samples collected over 36 hour period
Results posted on
2009-09-15
Participant Flow
Participant milestones
| Measure |
Glipizide Metformin (Test) First
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
|
Metaglip™ (Reference) First
Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
20
|
20
|
|
First Intervention
COMPLETED
|
20
|
20
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout: 7 Days
STARTED
|
20
|
20
|
|
Washout: 7 Days
COMPLETED
|
19
|
20
|
|
Washout: 7 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
19
|
20
|
|
Second Intervention
COMPLETED
|
19
|
20
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Glipizide Metformin (Test) First
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
|
Metaglip™ (Reference) First
Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
|
|---|---|---|
|
Washout: 7 Days
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
Baseline characteristics by cohort
| Measure |
Glipizide Metformin (Test) First
n=20 Participants
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
|
Metaglip™ (Reference) First
n=20 Participants
Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Anerican
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Glipizide Metformin
n=39 Participants
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
|
Metaglip™
n=39 Participants
Metaglip™ 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration) - Glipizide in Plasma
|
377.949 ng/mL
Standard Deviation 92.6166
|
381.282 ng/mL
Standard Deviation 96.1909
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Glipizide Metformin
n=39 Participants
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
|
Metaglip™
n=39 Participants
Metaglip™ 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glipizide
|
2214.7 ng*h/mL
Standard Deviation 664.87
|
2204.7 ng*h/mL
Standard Deviation 674.77
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Glipizide Metformin
n=39 Participants
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
|
Metaglip™
n=39 Participants
Metaglip™ 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide
|
2197.6 ng*h/mL
Standard Deviation 659.57
|
2188.2 ng*h/mL
Standard Deviation 668.99
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Glipizide Metformin
n=39 Participants
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
|
Metaglip™
n=39 Participants
Metaglip™ 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration) - Metformin in Plasma
|
661.03 ng/mL
Standard Deviation 149.301
|
644.64 ng/mL
Standard Deviation 111.631
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis. Data from one completed subject could not be used to estimate AUC0-inf.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Glipizide Metformin
n=39 Participants
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
|
Metaglip™
n=38 Participants
Metaglip™ 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin
|
4397.8 ng*h/mL
Standard Deviation 911.72
|
4423.2 ng*h/mL
Standard Deviation 781.62
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Glipizide Metformin
n=39 Participants
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
|
Metaglip™
n=39 Participants
Metaglip™ 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin
|
4220.7 ng*h/mL
Standard Deviation 900.20
|
4233.5 ng*h/mL
Standard Deviation 750.65
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER