Overview

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).