Trials / Completed
CompletedNCT00939926
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
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Torrent Pharmaceuticals Limited · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- —
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 fed conditions. Study Design: * A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Risperidone |
Timeline
- First posted
- 2009-07-15
- Last updated
- 2017-10-24
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT00939926. Inclusion in this directory is not an endorsement.