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.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
1 x 15/25 mg
1 x 15/25 mg
Gateway Medical Research, Inc.
Saint Charles, Missouri, United States
Bioassay Laboratory, Inc.
Houston, Texas, United States
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.
Bioequivalence based on Cmax.
Time frame: Blood samples collected over a 192 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.
Bioequivalence based on AUC0-t.
Time frame: Blood samples collected over a 192 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.
Bioequivalence based on AUC0-inf.
Time frame: Blood samples collected over a 192 hour period.
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.
Bioequivalence based on Cmax.
Time frame: Blood samples collected over a 192 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.
Bioequivalence based on AUC0-t.
Time frame: Blood samples collected over a 192 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.
Bioequivalence based on AUC0-inf.
Time frame: Blood samples collected over a 192 hour period.
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.
Informational comparison of Cmax values for the metabolite Moexiprilat.
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Time frame: Blood samples collected over a 192 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.
Informational comparison of AUC0-t values for the metabolite Moexiprilat.
Time frame: Blood samples collected over a 192 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.
Informational comparison of AUC0-inf values for the metabolite Moexiprilat.
Time frame: Blood samples collected over a 192 hour period.