Trial Outcomes & Findings for 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting (NCT NCT00835497)

NCT ID: NCT00835497

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	20	20
Washout: 7 Days NOT COMPLETED	0	0
Second Intervention STARTED	20	20
Second Intervention COMPLETED	20	20
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, 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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Glipizide Metformin n=40 Participants Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period	Metaglip® n=40 Participants Metaglip® 5/500 mg Tablet (reference) dosed in either period
Cmax (Maximum Observed Concentration) - Glipizide in Plasma	337.100 ng/mL Standard Deviation 69.6511	392.150 ng/mL Standard Deviation 94.7365

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: 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=40 Participants Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period	Metaglip® n=40 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	2032.8 ng*h/mL Standard Deviation 655.53	2092.9 ng*h/mL Standard Deviation 684.16

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: 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=40 Participants Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period	Metaglip® n=40 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	2005.8 ng*h/mL Standard Deviation 638.50	2065.1 ng*h/mL Standard Deviation 667.92

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Glipizide Metformin n=40 Participants Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period	Metaglip® n=40 Participants Metaglip® 5/500 mg Tablet (reference) dosed in either period
Cmax (Maximum Observed Concentration) - Metformin in Plasma	640.00 ng/mL Standard Deviation 120.249	724.98 ng/mL Standard Deviation 172.939

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: 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=40 Participants Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period	Metaglip® n=40 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	3912.0 ng*h/mL Standard Deviation 738.53	4212.7 ng*h/mL Standard Deviation 787.61

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: 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=40 Participants Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period	Metaglip® n=40 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	3701.3 ng*h/mL Standard Deviation 712.00	3979.2 ng*h/mL Standard Deviation 793.07

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

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