Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions

• Status: Completed
• Trial end date: 2002-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.

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

Details

• Lead Sponsor: Teva Pharmaceuticals USA
• Treatments: Anticonvulsants; Lamotrigine

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

Subjects to whom any of the following applies will be excluded from the study:

• 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.

• Subjects with a history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.

• Any reason which, in the opinion of the medical subinvestigator, would prevent 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; or heart rate less than 50 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 subinvestigator, contraindicates the subject's participation in this study.

• History of allergic reactions to lamotrigine.

• 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, valproic acid, use of an investigational drug or participation on an investigation study within 30 days prior to the 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 a supplement) 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 used tobacco in any form within the 90 days preceding study drug administration.

Additional exclusion criteria for female subjects only:

• Breast feeding subjects.

• Positive urine pregnancy test at screening (performed on all females).