Trial Outcomes & Findings for Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects (NCT NCT00834795)

NCT ID: NCT00834795

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 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 followed 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	18	18
First Intervention COMPLETED	18	18
First Intervention NOT COMPLETED	0	0
Washout: 7 Days STARTED	18	18
Washout: 7 Days COMPLETED	18	17
Washout: 7 Days NOT COMPLETED	0	1
Second Intervention STARTED	18	17
Second Intervention COMPLETED	17	17
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Carvedilol (Test) First Carvedilol 25 mg Tablet (test) dosed in first period followed 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
Washout: 7 Days Withdrawal by Subject	0	1
Second Intervention Adverse Event	1	0

Baseline Characteristics

Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

Baseline characteristics by cohort

Measure	Carvedilol (Test) First n=18 Participants Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period	Coreg® (Reference) First n=18 Participants Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period	Total n=36 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	18 Participants n=5 Participants	18 Participants n=7 Participants	36 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	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 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=34 Participants Carvedilol 25 mg Tablet (test) dosed in either period	Coreg® n=34 Participants Coreg® 25 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Carvedilol in Plasma	104.98 ng/mL Standard Deviation 57.81	107.47 ng/mL Standard Deviation 57.95

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=34 Participants Carvedilol 25 mg Tablet (test) dosed in either period	Coreg® n=34 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	465.29 ng*h/mL Standard Deviation 304.00	468.81 ng*h/mL Standard Deviation 282.83

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=34 Participants Carvedilol 25 mg Tablet (test) dosed in either period	Coreg® n=34 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	454.24 ng*h/mL Standard Deviation 303.44	456.05 ng*h/mL Standard Deviation 279.95

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