Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions

NCT00944242 | Completed Phase 1

• 1 other identifier: 40485
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

• Objective:
• To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a 1X100 mg tablet, under fasted conditions.
• Study Design:
• Single-dose, open-label, randomized two-way crossover.

Conditions

Healthy

Interventions

Sertraline DRUG

Sertraline Hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, smoker or non smoker, 18 years of age and older.
• Capable of consent.
• BMI\>= 19.0 and \<30.0 kg/m2

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.
• Positive testing for hepatitis B, hepatitis C, or HIV at screening.
• ECG abnormalities or vital sign abnormalities(blood pressure).
• History of significant alcohol or drug abuse within one year prior to the screening visit.
• History or allergic reactions to heparin, sertraline or other related drugs.
• Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication.
• Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
• History of seizures, suicide attempt, bipolar disorder or manic episodes.
• Depot injection or an implant of any drugs with in 6 months prior to administration of study medication.
• Breastfeeding subject.
• Positive urine pregnancy test at screening.
• female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration.
• Acceptable methods of contraception:
• Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration)

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

Anapharm Inc.

Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Last Updated: July 23, 2009

Record last verified: 2009-07

Locations

CA (1)