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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Fluoxetine Hydrochloride

• Registration Number: NCT01166087
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-03
• Study Completion: 2006-09
• Status Verified: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Last Update Submitted: 2010-07-20
• Last Update Posted: 2010-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prozac ® weekly	Fluoxetine Hydrochloride	Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company
Fluoxetine Hydrochloride	Fluoxetine Hydrochloride	Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax and AUC parameters	8 months

Trial Locations

Locations (1)

Lotus Labs Private Limited; 🇮🇳 Mylapore, Chennai, India