The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fasting conditions and to monitor the adverse events and ensure the safety of the subjects.
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Olanzapine Tablets 5 mg of Dr. Reddy's Laboratories Limited, India, comparing with that of Zyprexa® (Olanzapine) Tablets 5 mg of Eli Lilly and Company, USA, in healthy, adult, human subjects under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Olanzapine Tablets, 5 mg
Lambda Therapeutic Research Ltd.,
Ahmedabad, Gujarat, India
Bioequivalence is based on Cmax and AUC parameters
Time frame: 2 months
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