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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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 and Prozac®Weekly 90 mg DR Capsules of Eli Lilly and Company, USA in Healthy Adult Human Subjects Under Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fluoxetine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoxetine Hydrochloride<br>Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited | Drug: Fluoxetine Hydrochloride<br>* Fluoxetine Hydrocloride Delayed Release Capsules, 90 mg of Dr. Reddy's Laboratories.<br>* Other names: Prozac ® weekly 90 mg Delayed-Release Capsules;|
| Active Comparator: Prozac ® weekly TM<br>Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company | Drug: Fluoxetine Hydrochloride<br>* Fluoxetine Hydrocloride Delayed Release Capsules, 90 mg of Dr. Reddy's Laboratories.<br>* Other names: Prozac ® weekly 90 mg Delayed-Release Capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on Cmax and AUC parameters |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Crossover, Fluoxetine Hydrochloride