bioequivalence study of 200 mg lamotrigine tablet under non-fasting conditions

Conditions: Healthy

Summary: the objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.

criteria for evaluation: fda bioequivalence criteria statistical methods: fda bioequivalence statistical methods

Eligibility 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).

Keywords: bioequivalence healthy subjects