Information obtained from ClinicalTrials.gov on September 02, 2010
Link to the current ClinicalTrials.gov record.
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Under Fasting Condition
Status: Completed
Verified by: Dr. Reddy's Laboratories Limited, July 2010
Last Updated: July 20, 2010
Sponsor: Dr. Reddy's Laboratories Limited
Purpose
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.
Condition: Healthy
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention: Drug: Fluoxetine Hydrochloride
Phase: Phase 1
Primary Outcome Measures:
- Bioequivalence based on Cmax and AUC parameters
Estimated Enrollment: 54
Start Date: February 2006
Primary Completion Date: March 2006
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 fasting
conditions.
Eligibility
Minimum Age: 18 Years
Maximium Age: 50 Years
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Gender: Both
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.
Location and Contacts
Contact: Dr. James John, MBBS, MD, Principal Investigator, Lotus Labs Private Limited
Lotus Labs Private Limited
Mylapore,
Chennai,
600 004
India