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Bioequivalence Study 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 Fasting Conditions

NCT00939497 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-10-24

No results posted yet for this study

Summary

Objective:

* 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 fasting conditions.

Study Design:

* A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Risperidone

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939497 on ClinicalTrials.gov