Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Under Fasting Condition
NCT00940238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2017-10-24
Summary
* Objective:
* To compare the rate and extent of absorption of Citalopram Hydrobromide Tablets 40 mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: CelexaTM Tablets 40 mg (Reference Listed Drug) manufactured by Forest Pharmaceuticals Inc., Missouri under fasting conditions in 36 healthy, adult, human subjects in a randomized crossover study.
* Study Design:
* Open-label, randomized, two period crossover studies in 36(Fasting)healthy, normal subjects to compare the single dose bioavailability of Torrent's Citalopram Hydrobromide tablets 40 mg and Forest Pharmaceutical's Celexa 40mg tablets.
Conditions
- Healthy
Interventions
- DRUG
-
Citalopram Hydrobromide
Sponsors & Collaborators
-
Torrent Pharmaceuticals Limited
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- India
Study Locations
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