NCT00840073

Trandolapril 4 mg Tablet Under Non-Fasting Conditions

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Trandolapril 4 mg Tablets Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the comparative bioavailability between trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in healthy subjects under fed 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 fed
DRUG	Mavik® 4 mg Tablets	1 x 4 mg, single-dose fed

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