Sertraline Hydrochloride 100 mg Tablets, Fed

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Sertraline hydrochloride 100 mg Tablets; Drug: Zoloft® 100 mg Tablets

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sainte-Foy, Quebec, Canada, GIV2K8
      • Anapharm Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Cmax and AUC	3 weeks

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): April 1, 2002
• Study Completion (Actual): April 1, 2002

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Estimate): February 4, 2009
• Last Update Submitted That Met QC Criteria: February 3, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: 02071