Trial Outcomes & Findings for Trandolapril 4 mg Tablet Under Fasting Conditions (NCT NCT00840632)
NCT ID: NCT00840632
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Blood samples collected over 24 hour period
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Trandolapril (Test) First
Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
|
Mavik® (Reference) First
Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
20
|
20
|
|
First Intervention
COMPLETED
|
20
|
19
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Washout
STARTED
|
20
|
19
|
|
Washout
COMPLETED
|
19
|
18
|
|
Washout
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
19
|
18
|
|
Second Intervention
COMPLETED
|
19
|
18
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Trandolapril (Test) First
Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
|
Mavik® (Reference) First
Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
1
|
|
Washout
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Trandolapril 4 mg Tablet Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Trandolapril (Test) First
n=20 Participants
Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
|
Mavik® (Reference) First
n=20 Participants
Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
|
Total
n=40 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
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Trandolapril
n=37 Participants
Trandolapril 4 mg Tablet (test) dosed in either period
|
Mavik®
n=37 Participants
Mavik® 4 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
4559.54 pg/mL
Standard Deviation 2269.88
|
4872.59 pg/mL
Standard Deviation 2218.00
|
PRIMARY outcome
Timeframe: Blood samples collected over 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Trandolapril
n=37 Participants
Trandolapril 4 mg Tablet (test) dosed in either period
|
Mavik®
n=37 Participants
Mavik® 4 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
4868.37 pg*h/mL
Standard Deviation 2340.05
|
4826.71 pg*h/mL
Standard Deviation 2022.13
|
PRIMARY outcome
Timeframe: Blood samples collected over 24 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Trandolapril
n=37 Participants
Trandolapril 4 mg Tablet (test) dosed in either period
|
Mavik®
n=37 Participants
Mavik® 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 (Per Participant)
|
4609.82 pg*h/mL
Standard Deviation 2178.05
|
4612.53 pg*h/mL
Standard Deviation 1897.96
|
SECONDARY outcome
Timeframe: Blood samples collected over 72 hour periodInformational Purposes Only
Outcome measures
| Measure |
Trandolapril
n=37 Participants
Trandolapril 4 mg Tablet (test) dosed in either period
|
Mavik®
n=37 Participants
Mavik® 4 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Trandolaprilat
|
6682.74 pg/mL
Standard Deviation 2005.26
|
6526.16 pg/mL
Standard Deviation 1961.47
|
SECONDARY outcome
Timeframe: Blood samples collected over 72 hour periodInformational Purposes Only
Outcome measures
| Measure |
Trandolapril
n=37 Participants
Trandolapril 4 mg Tablet (test) dosed in either period
|
Mavik®
n=37 Participants
Mavik® 4 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Trandolaprilat
|
138305.28 pg*h/mL
Standard Deviation 25043.67
|
138925.03 pg*h/mL
Standard Deviation 29142.49
|
SECONDARY outcome
Timeframe: Blood samples collected over 72 hour periodInformational Purposes Only
Outcome measures
| Measure |
Trandolapril
n=37 Participants
Trandolapril 4 mg Tablet (test) dosed in either period
|
Mavik®
n=37 Participants
Mavik® 4 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Trandolaprilat
|
111204.01 pg*h/mL
Standard Deviation 18419.42
|
111685.36 pg*h/mL
Standard Deviation 20122.99
|
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