Trials / Completed
CompletedNCT01634386
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fasting Conditions
An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Single-dose Bioequivalence Study of Quetiapine 25 mg Tablet [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 25 mg Tablet [Reference Formulation; AstraZeneca, USA] in Healthy Human Volunteers Under Fasting Condition.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Torrent Pharmaceuticals Limited · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Objective: Primary objective of the present study was to compare the single dose bioequivalence of Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by a washout period of 7 days. Study Design: Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Torrent's Quetiapine Fumarate Tablets |
Timeline
- First posted
- 2012-07-06
- Last updated
- 2012-07-06
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT01634386. Inclusion in this directory is not an endorsement.