drugset / Trial / NCT00829452

Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions

NCT00829452 ↗

Phase 1 Completed 40 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference) administered as the content of 1 x 10 mg capsule mixed with applesauce under fasting conditions.

Timeline

Start
2004-08
Primary completion
2004-10
Completion
2004-10

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 96.03 (90% CI 89.11 to 103.49) NCT00829452 ↗

registry Ratio of the T/R geometric mean x 100 95.34 (90% CI 90.82 to 100.09) NCT00829452 ↗

registry Ratio of the T/R geometric mean x 100 96.98 (90% CI 92.73 to 101.42) NCT00829452 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramipril Small molecule 10 mg —

Indications

No indication recorded.