To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under non-fasting conditions and to assess the bioequivalence.
This was an open-label, balanced, randomized, two-treatment, two-period, two-sequence,single dose, crossover bioequivalence study in healthy, adult, human, male subjects under non-fasting conditions.92 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500 mg was administered orally with 240 mL water in sitting posture, after 30 minutes of serving of the high fat and high calorie breakfast in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first three hours after dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Mycophenolate Mofetil 500 mg tablets
Lambda Therapeutic Research Ltd
Bodakdev, Ahmedabad, India
Bioequivalence on Cmax and AUC parameters
Time frame: 3 months
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