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Lamotrigine 25 mg Chewable Tablets, Non-Fasting

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Lamotrigine 25 mg Chewable Tablets (Drug); Lamictal® 25 mg Chewable Tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Eric Bicrell, M.D., Principal Investigator, Affiliation: Anapharm

Summary

The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fed conditions.

Clinical Details

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Dispersible Tablets and Lamictal® 25 mg Chewable Dispersible Tablets in Healthy Subjects Under Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Concentration

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 or

hysterectomy with bilateral oophorectomy at least 6 months ago.

- 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 the 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 sub-investigator, 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 (PVP) 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 lamotrigine.

- Use of any drugs known to induce or inhibit 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 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) 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.

- Subjects who have dentures or braces.

- Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to

administration of the study medication as follow: less than 300 mL of whole blood within 30 days; 300 mL to 500 mL of whole blood within 45 days; 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 90 days preceding study drug

administration.

- Female subjects: breast-feeding subjects.

- Female subjects: positive urine pregnancy test at screening.

Locations and Contacts

Anapharm Inc., Sainte-Foy, Quebec GIV2K8, Canada
Additional Information

Starting date: February 2002
Last updated: September 1, 2009

Page last updated: August 23, 2015

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