The purpose of this study is to * compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fed conditions * monitor adverse events and to ensure the safety of subjects.
A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Simvastatin 80 mg tablets of Dr. Reddy's Laboratories Limited to be compared with Zocor® 80 mg tablets of Merck \& Co. Inc., USA in healthy, adult, human subjects under fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
Bioequivalence based on Cmax and AUC parameters
Time frame: 4 months
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