drugset / Trial / NCT00840073

Trandolapril 4 mg Tablet Under Non-Fasting Conditions

NCT00840073 ↗

Phase 1 Completed 50 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2004-10
Primary completion
2004-11
Completion
2004-11

Outcome

Met primary endpoint

registry Ratio of Geometric Means 96.00 (90% CI 85.13 to 108.27) NCT00840073 ↗

registry Ratio of Geometric Means 103.81 (90% CI 96.72 to 111.41) NCT00840073 ↗

registry Ratio of Geometric Means 102.37 (90% CI 97.34 to 107.65) NCT00840073 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject trandolapril Small molecule 4 mg —

Indications

No indication recorded.