drugset / Trial / NCT00828321

Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions

NCT00828321 ↗

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 1 x 10 mg capsule 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 94.16 (90% CI 85.08 to 104.21) NCT00828321 ↗

registry Ratio of the T/R geometric mean x 100 102.22 (90% CI 96.21 to 108.6) NCT00828321 ↗

registry Ratio of the T/R geometric mean x 100 102.22 (90% CI 96.34 to 108.58) NCT00828321 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramipril Small molecule 10 mg —

Indications

No indication recorded.