Trandolapril 4 mg Tablet Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Mavik® 4 mg Tablets; Drug: Trandolapril 4 mg Tablets

• Registration Number: NCT00840632
• Lead Sponsor: Teva Pharmaceuticals USA

Brief Summary

The objective of this study is to compare the rate and extent of absorption of trandolapril from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets under fasting conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-10
• Results First Submitted: 2009-07-06
• Results First Submitted QC: 2009-07-06
• Results First Posted: 2009-08-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mavik®	Mavik® 4 mg Tablets	Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
Trandolapril	Trandolapril 4 mg Tablets	Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period

Primary Outcome Measures

Name	Time	Method
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	Blood samples collected over 24 hour period	Bioequivalence based on AUC0-t
Cmax - Maximum Observed Concentration	Blood samples collected over 24 hour period	Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	Blood samples collected over 24 hour period	Bioequivalence based on AUC0-inf

Secondary Outcome Measures

Name	Time	Method
Cmax - Trandolaprilat	Blood samples collected over 72 hour period	Informational Purposes Only
AUC0-inf - Trandolaprilat	Blood samples collected over 72 hour period	Informational Purposes Only
AUC0-t - Trandolaprilat	Blood samples collected over 72 hour period	Informational Purposes Only

Trial Locations

Locations (1)

Biovail Contract Research; 🇨🇦 Toronto, Ontario, Canada