Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions

Phase 1 Completed 60 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to compare the relative bioavailability of Moexipril HCl/hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult non-smoking subjects under fasting conditions.

Timeline

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

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 92.5 (90% CI 85.8 to 99.8) NCT00835042 ↗

registry Ratio of the T/R geometric mean x 100 98.9 (90% CI 92.2 to 106) NCT00835042 ↗

registry Ratio of the T/R geometric mean x 100 99.1 (90% CI 92.3 to 106) NCT00835042 ↗

registry Ratio of the T/R geometric mean x 100 105 (90% CI 99.3 to 111) NCT00835042 ↗

registry Ratio of the T/R geometric mean x 100 99.1 (90% CI 96.4 to 102) NCT00835042 ↗

registry Ratio of the T/R geometric mean x 100 99.3 (90% CI 96.7 to 102) NCT00835042 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydrochlorothiazide	Unknown	25 mg	—
Subject	Moexipril	Small molecule	15 mg	—

Indications

No indication recorded.