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

NCT ID: NCT01166087

Last Updated: 2010-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-09-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Fluoxetine Hydrochloride

Intervention Type: DRUG

Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.

Prozac ® weekly

Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company

Group Type: ACTIVE_COMPARATOR

Fluoxetine Hydrochloride

Intervention Type: DRUG

Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.

Interventions

Fluoxetine Hydrochloride

Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.

Intervention Type: DRUG

Other Intervention Names

Prozac ® weekly 90 mg Delayed Release Capsules

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's Laboratories Limited

Principal Investigators

Dr. James John, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Lotus Labs Private Limited

Locations

Lotus Labs Private Limited

Mylapore, Chennai, India

Countries

India

Other Identifiers

586/05

Identifier Type: -

Identifier Source: org_study_id