Trial Outcomes & Findings for Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects (NCT NCT00834873)

NCT ID: NCT00834873

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Blood samples collected over 60 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Carvedilol (Test) First Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period	Coreg® (Reference) First Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
First Intervention STARTED	12	12
First Intervention COMPLETED	12	11
First Intervention NOT COMPLETED	0	1
Washout: 7 Days STARTED	12	11
Washout: 7 Days COMPLETED	12	11
Washout: 7 Days NOT COMPLETED	0	0
Second Intervention STARTED	12	11
Second Intervention COMPLETED	12	11
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Carvedilol (Test) First Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period	Coreg® (Reference) First Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
First Intervention Adverse Event	0	1

Baseline Characteristics

Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects

Baseline characteristics by cohort

Measure	Carvedilol (Test) First n=12 Participants Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period	Coreg® (Reference) First n=12 Participants Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period	Total n=24 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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Caucasion	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 60 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Carvedilol n=23 Participants Carvedilol 25 mg Tablet (test) dosed in either period	Coreg® n=23 Participants Coreg® 25 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Carvedilol in Plasma	89.91 ng/mL Standard Deviation 40.86	97.05 ng/mL Standard Deviation 49.61

PRIMARY outcome

Timeframe: Blood samples collected over 60 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	Carvedilol n=23 Participants Carvedilol 25 mg Tablet (test) dosed in either period	Coreg® n=23 Participants Coreg® 25 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma	467.57 ng*h/mL Standard Deviation 287.12	490.16 ng*h/mL Standard Deviation 337.58

PRIMARY outcome

Timeframe: Blood samples collected over 60 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	Carvedilol n=23 Participants Carvedilol 25 mg Tablet (test) dosed in either period	Coreg® n=23 Participants Coreg® 25 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) - Carvedilol in Plasma	455.91 ng*h/mL Standard Deviation 284.99	478.61 ng*h/mL Standard Deviation 336.07

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