Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-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 non-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 96.7 (90% CI 90.1 to 104) NCT00834067 ↗

registry Ratio of the T/R geometric mean x 100 104 (90% CI 99.9 to 108) NCT00834067 ↗

registry Ratio of the T/R geometric mean x 100 103 (90% CI 99.7 to 107) NCT00834067 ↗

registry Ratio of the T/R geometric mean x 100 101 (90% CI 96 to 106) NCT00834067 ↗

registry Ratio of the T/R geometric mean x 100 101 (90% CI 99.1 to 102) NCT00834067 ↗

registry Ratio of the T/R geometric mean x 100 101 (90% CI 99.4 to 103) NCT00834067 ↗

Drugs

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

Indications

No indication recorded.