Sertraline Hydrochloride 100 mg Tablets, Fed

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00836667
First received: February 3, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

The objective of this study is to compare the rate and extent of absorption of sertraline hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg tablet under fed conditions.


Condition Intervention Phase
Healthy
Drug: Zoloft® 100 mg Tablets
Drug: Sertraline hydrochloride 100 mg Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets and Zoloft® 100 mg Tablets Administered as 1 x 100 mg Tablet in Healthy Subjects Under Fed Conditions.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2002
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sertraline hydrochloride 100 mg Tablets
1 x 100 mg, single-dose fed
Active Comparator: 2 Drug: Zoloft® 100 mg Tablets
1 x 100 mg, single-dose fed

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be females and/or males, non-smokers, 18 years of age and older. Female subjects will be post-menopausal or surgically sterilized.
  • Post-menopausal status is defined as absence of menses for the past 12 months.
  • Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Exclusion Criteria:

  • Clinically significant illnesses within 4 weeks of the administration of study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the medical sub-investigator, would preven the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
  • Positive urine drug screen at screening
  • Positive testing for hepatitis B, hepatitis C or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHG, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
  • Subjects with BMI ≥ 30.0.
  • History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%)
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
  • History of allergic reactions to sertraline or other related drugs (e.g. fluoxetine hydrochloride, fluvoxamine hydrochloride, paroxetine hydrochloride).
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement and products containing dextromethorphan) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows: less than 300 mL of whole blood within 30 days or; 300 mL to 500 mL of whole blood within 45 days or; more than 500 mL of whole blood within 56 days.
  • Positive alcohol breath test at screening.
  • Subjects who have consumed food or beverages containing grapefruit (3.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
  • Past history of bipolar affective disorder or other active psychiatric diagnosis.
  • History of seizures.
  • Subjects with a clinically significant history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
  • Intolerance to venipuncture.
  • Breast-feeding subjects.
  • Positive urine pregnancy test at screening (performed on all females).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836667

Locations
Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada, GIV2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Benoit Girard, M.D. Anapharm
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00836667     History of Changes
Other Study ID Numbers: 02071
Study First Received: February 3, 2009
Last Updated: February 3, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014