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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
18 participants
n=107 Participants
|
36 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 60 hour periodPopulation: 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 periodPopulation: 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 periodPopulation: 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
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