Healthy
Conditions
Keywords
Bioequivalence, Crossover, Fluoxetine Hydrochloride
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.
Interventions
Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence based on Cmax and AUC parameters | 8 months |
Countries
India
Outcome results
None listed