Trial Outcomes & Findings for Trandolapril 4 mg Tablet Under Non-Fasting Conditions (NCT NCT00840073)

NCT ID: NCT00840073

Last Updated: 2024-08-20

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 50 participants
• Primary outcome timeframe: Blood samples collected over 72 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	25	25
First Intervention COMPLETED	25	25
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	25	25
Second Intervention COMPLETED	24	24
Second Intervention NOT COMPLETED	1	1

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
Second Intervention Missed 72 hour blood draw	1	1

Baseline Characteristics

Trandolapril 4 mg Tablet Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Trandolapril (Test) First n=25 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=25 Participants Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period	Total n=50 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	25 Participants n=5 Participants	25 Participants n=7 Participants	50 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	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.

Bioequivalence based on Cmax

Outcome measures

Measure	Trandolapril n=50 Participants Trandolapril 4 mg Tablet (test) dosed in either period	Mavik® n=50 Participants Mavik® 4 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	5.2604 ng/mL Standard Deviation 3.8238	5.4938 ng/mL Standard Deviation 3.7393

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis. Not all data from completed subjects could be used to determine AUC0-inf.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Trandolapril n=20 Participants Trandolapril 4 mg Tablet (test) dosed in either period	Mavik® n=22 Participants Mavik® 4 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	7.0104 ng*h/mL Standard Deviation 1.9298	7.9967 ng*h/mL Standard Deviation 2.8867

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Trandolapril n=50 Participants Trandolapril 4 mg Tablet (test) dosed in either period	Mavik® n=50 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)	6.9056 ng*h/mL Standard Deviation 2.7329	6.7143 ng*h/mL Standard Deviation 2.4740

SECONDARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.

Informational Purposes Only

Outcome measures

Measure	Trandolapril n=50 Participants Trandolapril 4 mg Tablet (test) dosed in either period	Mavik® n=50 Participants Mavik® 4 mg Tablet (reference) dosed in either period
Cmax - Trandolaprilat	6.9610 ng/mL Standard Deviation 2.5672	6.6815 ng/mL Standard Deviation 2.4413

SECONDARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.

Informational Purposes Only

Outcome measures

Measure	Trandolapril n=50 Participants Trandolapril 4 mg Tablet (test) dosed in either period	Mavik® n=50 Participants Mavik® 4 mg Tablet (reference) dosed in either period
AUC0-72 - Trandolaprilat	127.6059 ng*h/mL Standard Deviation 23.9616	123.4560 ng*h/mL Standard Deviation 22.6436

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