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| Sponsor: | Dr. Reddy's Laboratories Limited |
|---|---|
| Information provided by: | Dr. Reddy's Laboratories Limited |
| ClinicalTrials.gov Identifier: | NCT01166100 |
Purpose
The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg and Prozac ® weekly under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Fluoxetine Hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's and Prozac®Weekly 90 mg DR Capsules of Eli Lilly and Company, USA in Healthy Adult Human Subjects Under Fasting Conditions |
| Enrollment: | 54 |
| Study Start Date: | February 2006 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fluoxetine Hydrochloride
Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited
|
Drug: Fluoxetine Hydrochloride
Fluoxetine Hydrocloride Delayed Release Capsules, 90 mg of Dr. Reddy's Laboratories.
Other Name: Prozac ® weekly 90 mg Delayed-Release Capsules
|
|
Active Comparator: Prozac ® weekly TM
Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company
|
Drug: Fluoxetine Hydrochloride
Fluoxetine Hydrocloride Delayed Release Capsules, 90 mg of Dr. Reddy's Laboratories.
Other Name: Prozac ® weekly 90 mg Delayed-Release Capsules
|
A randomized, open label, two treatment, two period, two sequence, single dose, crossover bioequivalence study of Fluoxetine Hydrochloride delayed release capsules 90 mg of Dr. Reddy's laboratories limited, Generics, India and Prozac®weekly 90 mg delayed release capsules of Eli Lilly and company, USA in healthy adult human subjects under fasting conditions.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Female Subjects
Exclusion Criteria:
Contacts and Locations| India | |
| Lotus Labs Private Limited | |
| Mylapore, Chennai, India, 600 004 | |
| Principal Investigator: | Dr. James John, MBBS, MD | Lotus Labs Private Limited |
More Information
| Responsible Party: | Mr. M.S. Mohan / Vice President (Research and Development), Dr. Reddy's Laboratories Limited |
| ClinicalTrials.gov Identifier: | NCT01166100 History of Changes |
| Other Study ID Numbers: | 587/05 |
| Study First Received: | July 19, 2010 |
| Last Updated: | July 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Bioequivalence Crossover Fluoxetine Hydrochloride |
|
Fluoxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents |
Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |