Bioequivalence Study of Risperidone 1 mg Tablets of Torrent Pharmaceuticals Limited, India and Risperdal® (Risperidone) 1 mg Tablets of Janssen Pharmaceutical Products, LP, USA, in Healthy Human Adult Subjects, Under Fed Conditions
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To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical Products, LP, USA, in healthy human adult subjects, under fed conditions.
A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.
Bioequivalence Study of Risperidone 1 mg Tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1 mg Tablets of Janssen Pharmaceutical Products, LP, USA, in Healthy Human Adult Subjects, Under Fed Conditions
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Healthy adult subjects of either sex between 18-55 years of age (inclusive) have a body mass index (BMI) between 18 and 27 kg/m2.
Subjects who had no evidence of underlying disease during screening and whose physical examination was performed within 21 days prior to commencement of the study.
Subjects whose screening laboratory values were within normal limits or considered by the Investigator to be of no clinical significance.
Informed consent given in written form according to section 11.3 of the protocol.
of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the Investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine contraceptive device, (IUD) or abstinence.