Overview

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

Status:
Completed
Trial end date:
2006-09-01
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 fed 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.