Status:
COMPLETED
Sertraline Hydrochloride 100 mg Tablets, Fed
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 con...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2002
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00836667
Start Date
March 1 2002
End Date
April 1 2002
Last Update
August 19 2024
Active Locations (1)
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1
Anapharm Inc.
Sainte-Foy, Quebec, Canada, GIV2K8