Trial Outcomes & Findings for Glimepiride 4 mg Tablets Under Fasting Conditions (NCT NCT00834340)

NCT ID: NCT00834340

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: Blood samples collected over 24 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Glimepiride (Test) First Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period	Amaryl® (Reference) First Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
First Intervention STARTED	16	16
First Intervention COMPLETED	16	16
First Intervention NOT COMPLETED	0	0
Washout STARTED	16	16
Washout COMPLETED	14	16
Washout NOT COMPLETED	2	0
Second Intervention STARTED	14	16
Second Intervention COMPLETED	14	16
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Glimepiride (Test) First Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period	Amaryl® (Reference) First Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
Washout Adverse Event	1	0
Washout Withdrawal by Subject	1	0

Baseline Characteristics

Glimepiride 4 mg Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Glimepiride (Test) First n=16 Participants Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period	Amaryl® (Reference) First n=16 Participants Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period	Total n=32 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	16 Participants n=5 Participants	16 Participants n=7 Participants	32 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	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Biracial	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Glimepiride n=30 Participants Glimepiride 4 mg Tablet (test) dosed in either period	Amaryl® n=30 Participants Amaryl® 4 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	231.700 ng/mL Standard Deviation 97.290	226.890 ng/mL Standard Deviation 88.016

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

Population: The parameter of AUCinf could not be estimated for one subject.

Bioequivalence based on AUCinf

Outcome measures

Measure	Glimepiride n=29 Participants Glimepiride 4 mg Tablet (test) dosed in either period	Amaryl® n=29 Participants Amaryl® 4 mg Tablet (reference) dosed in either period
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	1613.846 ng*h/mL Standard Deviation 553.310	1660.082 ng*h/mL Standard Deviation 637.392

PRIMARY outcome

Timeframe: Blood samples collected over 24 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	Glimepiride n=30 Participants Glimepiride 4 mg Tablet (test) dosed in either period	Amaryl® n=30 Participants Amaryl® 4 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	1479.961 ng*h/mL Standard Deviation 524.507	1469.352 ng*h/mL Standard Deviation 548.723

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