Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01283867
Brief Summary:
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.
Detailed Description:
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:
NCT01283867
Study Brief:
Protocol Section:
NCT01283867