Status:
COMPLETED
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed Condition
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 li...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01166087
Start Date
February 1 2006
End Date
September 1 2006
Last Update
July 21 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lotus Labs Private Limited
Mylapore, Chennai, India, 600 004