Sertraline Hydrochloride 100 mg Tablets, Fed

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Teva Pharmaceuticals USA
• Treatments: Sertraline

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).