Trial Outcomes & Findings for Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting (NCT NCT00836472)

NCT ID: NCT00836472

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 60 participants
• Primary outcome timeframe: Blood samples collected over 36 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Glyburide Metformin (Test) First Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period	Glucovance® (Reference) First Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
First Intervention STARTED	30	30
First Intervention COMPLETED	30	30
First Intervention NOT COMPLETED	0	0
Washout STARTED	30	30
Washout COMPLETED	28	27
Washout NOT COMPLETED	2	3
Second Intervention STARTED	28	27
Second Intervention COMPLETED	28	27
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Glyburide Metformin (Test) First Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period	Glucovance® (Reference) First Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
Washout Adverse Event	1	2
Washout Withdrawal by Subject	1	1

Baseline Characteristics

Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting

Baseline characteristics by cohort

Measure	Glyburide Metformin (Test) First n=30 Participants Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period	Glucovance® (Reference) First n=30 Participants Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period	Total n=60 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	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	30 participants n=5 Participants	30 participants n=7 Participants	60 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	Glyburide Metformin n=55 Participants Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period	Glucovance® n=55 Participants Glucovance® 5/500 mg Tablet (reference) dosed in either period
Cmax (Maximum Observed Concentration) - Glyburide	106.46 ng/mL Standard Deviation 34.86	116.53 ng/mL Standard Deviation 52.35

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	Glyburide Metformin n=55 Participants Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period	Glucovance® n=55 Participants Glucovance® 5/500 mg Tablet (reference) dosed in either period
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide	805.92 ng*h/mL Standard Deviation 28813	806.89 ng*h/mL Standard Deviation 256.14

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	Glyburide Metformin n=55 Participants Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period	Glucovance® n=55 Participants Glucovance® 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)] - Glyburide	773.84 ng*h/mL Standard Deviation 276.56	781.35 ng*h/mL Standard Deviation 255.31

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	Glyburide Metformin n=55 Participants Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period	Glucovance® n=55 Participants Glucovance® 5/500 mg Tablet (reference) dosed in either period
Cmax (Maximum Observed Concentration) - Metformin	840.23 ng/mL Standard Deviation 249.06	889.45 ng/mL Standard Deviation 253.56

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	Glyburide Metformin n=55 Participants Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period	Glucovance® n=55 Participants Glucovance® 5/500 mg Tablet (reference) dosed in either period
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin	5915.32 ng*h/mL Standard Deviation 1663.04	6047.23 ng*h/mL Standard Deviation 1353.17

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	Glyburide Metformin n=55 Participants Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period	Glucovance® n=55 Participants Glucovance® 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	5798.89 ng*h/mL Standard Deviation 1660.66	5942.99 ng*h/mL Standard Deviation 1343.53

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