NCT01166087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2006

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
Last Updated

July 21, 2010

Status Verified

July 1, 2010

Enrollment Period

28 days

First QC Date

July 19, 2010

Last Update Submit

July 20, 2010

Conditions

Healthy

Keywords

BioequivalenceCrossoverFluoxetine Hydrochloride

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on Cmax and AUC parameters

    8 months

Study Arms (2)

Fluoxetine Hydrochloride

EXPERIMENTAL

Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited

Drug: Fluoxetine Hydrochloride

Prozac ® weekly

ACTIVE COMPARATOR

Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company

Drug: Fluoxetine Hydrochloride

Interventions

Fluoxetine HydrochlorideDRUG

Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.

Also known as: Prozac ® weekly 90 mg Delayed Release Capsules
Fluoxetine HydrochlorideProzac ® weekly

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lotus Labs Private Limited

Mylapore, Chennai, 600 004, India

Location

MeSH Terms

Interventions

Fluoxetine

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Dr. James John, MBBS, MD

    Lotus Labs Private Limited

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 20, 2010

Study Start

February 1, 2006

Primary Completion

March 1, 2006

Study Completion

September 1, 2006

Last Updated

July 21, 2010

Record last verified: 2010-07

Locations

IN(1)