NCT00840632

Trandolapril 4 mg Tablet Under Fasting Conditions

A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Trandolapril 4 mg Tablets Versus Mavik® 4 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Trandolapril 4 mg Tablets	1 x 4 mg, single-dose fasting
DRUG	Mavik® 4 mg Tablets	1 x 4 mg, single-dose fasting

Timeline

• Start date: 2004-10-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2009-02-10
• Last updated: 2024-08-20
• Results posted: 2009-08-18

Locations

1 site across 1 country: Canada