Status:
COMPLETED
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions
Lead Sponsor:
Torrent Pharmaceuticals Limited
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Male or female, smoker or non smoker, 18 years of age and older.
- Capable of consent.
- BMI\>= 19.0 and \<30.0 kg/m2
Exclusion
- 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)
- Condom or diaphragm + spermicide.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00944242
Last Update
July 23 2009
Active Locations (1)
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1
Anapharm Inc.
Montreal, Quebec, Canada