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

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 Delayed Release Capsules of Eli Lilly and Company, USA in Healthy Adult Human Subjects Under Fed Conditions.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Fluoxetine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Chennai
    • Mylapore, Chennai, India, 600 004
      • Lotus Labs Private Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Cmax and AUC parameters	8 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (Estimate): July 20, 2010

Study Record Updates

• Last Update Posted (Estimate): July 21, 2010
• Last Update Submitted That Met QC Criteria: July 20, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Crossover; Fluoxetine Hydrochloride
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: 586/05