Overview

Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablets Under Fed Conditions

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
Male
Summary
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Fluoxetine
Criteria
Inclusion Criteria:

- Sex: male

- Age: 18-45 years (inclusive both)

- Volunteer with BMI of 18.5-27 (inclusive both) kg/m2 with minimum of 50 kg weight.

- Healthy and willing to participate in the study.

- Volunteer willing to provide written informed consent.

- Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion Criteria:

- Inability to communicate or co-operate.

- Volunteers suffering from any chronic illness such as arthritis, asthma etc.

- History of pre-existing bleeding disorder.

- Clinically relevant abnormalities in the results of the laboratory screening
evaluation.

- Clinically significant abnormal ECG or Chest X-ray.

- HIV, HCV, HBsAg positive volunteers.

- History of significant blood loss due to any reason, including blood donation in the
past 3 months.

- Participation in any study within past 3 months,

- History of alcohol or drug abuse.

- History of consumption of prescribed medication since last 14days or OTC medication/
herbal remedies since last 7 days before beginning of the study. Positive to Breath
alcohol test.

- Positive to breath alcohol test.

- Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine,
barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.

- Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood
pressure less than 60 mm Hg or more than 89 mm Hg.

- Pulse rate less than 60/minute or more than 100/minute.

- Oral temperature less than 95°F or more than 98.9°F.

- Respiratory rate less than 10/minute or more than 20/minute.

- History of allergy to the test drug or any drug chemically similar to the drug under
investigation.

- Recent History of kidney or liver dysfunction.

- Volunteers suffering from any psychiatric (acute or chronic) disorder.

- Existence of any surgical or medical condition, which, in the judgment of the Chief
Investigator and/or clinical investigator/physician, might interfere with the
absorption; distribution,· metabolism or excretion of the drug or likely to compromise
the safety of Volunteers.