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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2006

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.

Interventions

  • Drug: Fluoxetine Hydrochloride
    • Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy’s Laboratories.

Arms, Groups and Cohorts

  • Experimental: Fluoxetine Hydrochloride
    • Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy’s Laboratories Limited
  • Active Comparator: Prozac ® weekly
    • Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence based on Cmax and AUC parameters
    • Time Frame: 8 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr. Reddy’s Laboratories Limited
  • Provider of Information About this Clinical Study
    • Mr. M.S. Mohan / Vice President (Research and Development), Dr. Reddy’s Laboratories Limited
  • Overall Official(s)
    • Dr. James John, MBBS, MD, Principal Investigator, Lotus Labs Private Limited

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