Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions

Phase 1 Completed 80 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fed conditions.

Timeline

Start: 2003-10
Primary completion: 2003-11
Completion: 2003-11

Outcome

Met primary endpoint

registry analysis (unspecified test); Losartan (Test) vs Cozaar® (Reference); Ratio of the T/R geometric mean x 100 111.95 (90% CI 101.84 to 123.06) NCT01124175 ↗

registry analysis (unspecified test); Losartan (Test) vs Cozaar® (Reference); Ratio of the T/R geometric mean x 100 105.97 (90% CI 103.61 to 108.39) NCT01124175 ↗

registry analysis (unspecified test); Losartan (Test) vs Cozaar® (Reference); Ratio of the T/R geometric mean x 100 105.67 (90% CI 103.32 to 108.07) NCT01124175 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Losartan	Other / unclassified	100 mg	—

Indications

No indication recorded.