Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of studies were separated by a washout period of 7 days.
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Rosuvastatin Calcium Tablets containing Rosuvastatin Calcium 40 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Crestor® 40 mg Tablets containing Rosuvastatin Calcium 40 mg (Reference , AstraZeneca Pharmaceuticals LP, USA) in Healthy Human Volunteers Under Fasting Condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
oral, crossover
oral, crossover
Cmax
Time frame: Pre-dose to 96 hours post-dose
AUC
Time frame: Pre-dose to 96 hours post-dose
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