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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Fluoxetine

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.