The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
100/25 mg Tablets
100/25 mg Tablets
PRACS Institute, Ltd.
Fargo, North Dakota, United States
Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Losartan Cmax.
Time frame: Blood samples collected over a 48 hour period.
AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Losartan AUC0-t.
Time frame: Blood samples collected over a 48 hour period.
AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on Losartan AUC0-inf.
Time frame: Blood samples collected over a 48 hour period.
Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Hydrochlorothiazide Cmax.
Time frame: Blood samples collected over a 48 hour period.
AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on Hydrochlorothiazide AUC0-t.
Time frame: Blood samples collected over a 48 hour period.
AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on Hydrochlorothiazide AUC0-inf.
Time frame: Blood samples collected over a 48 hour period.
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