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Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed Condition

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01166087
First received: July 19, 2010
Last updated: July 20, 2010
Last verified: July 2010
History of Changes
  Purpose

The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg and Prozac ® weekly under fed conditions.


Condition Intervention Phase
Healthy
 Drug: Fluoxetine Hydrochloride
 Phase 1

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 Delayed Release Capsules of Eli Lilly and Company, USA in Healthy Adult Human Subjects Under Fed Conditions.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2006
Study Completion Date: September 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
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

Detailed Description:

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 fed conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (11 Underweight and Overweight Min. & Max. Chart).
  • Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
  • Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
  • Informed consent given in written form according to section 11.3 of the protocol.

  • Female Subjects

    • of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies,diaphragm, intrauterine device, or abstinence.
    • postmenopausal for at least I year.
    • surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

  • Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
  • Alcohol dependence, Alcohol abuse, i.e., regular use of more than 2 units of alcohol or 10 units per week or a history of alcoholism (one unit of alcohol equals 1/2 1 of beer 200 ml wine or 50 ml (of spirits) within last 6 months or recovered alcoholics , or drug abuse within past 1 year.
  • Moderate to heavy smoking (> 10 cigarettes/day) or consumption of tobacco products.
  • History of difficulty in swallowing capsules.
  • Clinically significant illness within 4 weeks before the start of the study.
  • Asthma, urticaria or other allergic type reactions after taking any medication.
  • Positive urine drug screening, Human Immunodeficiency Virus, Hepatitis B & C tests.
  • Any history of hypersensitivity to fluoxetine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166087

Locations
India
Lotus Labs Private Limited
Mylapore, Chennai, India, 600 004
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. James John, MBBS, MD Lotus Labs Private Limited
  More Information

No publications provided

Responsible Party: Mr. M.S. Mohan / Vice President (Research and Development), Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01166087     History of Changes
Other Study ID Numbers: 586/05
Study First Received: July 19, 2010
Last Updated: July 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Crossover
Fluoxetine Hydrochloride

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 22, 2013