drugset / Trial / NCT01019590

Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

NCT01019590

Phase 1 Completed 36 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed conditions.

Timeline

Start
2006-11
Primary completion
2006-11
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrochlorothiazide Unknown 25 mg Oral
Subject Olmesartan medoxomil Unknown 40 mg Oral

Indications

No indication recorded.