The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck \& Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
20
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 Hydroclorothiazide(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.
Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)
Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.
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Time frame: Blood samples collected over a 48 hour period.
AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.
Time frame: Blood samples collected over a 48 hour period.
AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.
Time frame: Blood samples collected over a 48 hour period.