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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01166087
First received: July 19, 2010
Last updated: July 20, 2010
Last verified: July 2010

July 19, 2010
July 20, 2010
February 2006
March 2006   (final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01166087 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Fluoxetine Hydrochloride
Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.
Other Name: Prozac ® weekly 90 mg Delayed Release Capsules
  • Experimental: Fluoxetine Hydrochloride
    Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Fluoxetine Hydrochloride
  • Active Comparator: Prozac ® weekly
    Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company
    Intervention: Drug: Fluoxetine Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
September 2006
March 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01166087
586/05
Yes
Mr. M.S. Mohan / Vice President (Research and Development), Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Dr. James John, MBBS, MD Lotus Labs Private Limited
Dr. Reddy's Laboratories Limited
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP