Lamotrigine 25 mg Chewable Tablets, Fasting
Overview[ - collapse ][ - ]
Purpose | 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 fasting conditions. |
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Condition | Healthy |
Intervention | Drug: Lamotrigine 25 mg Chewable Tablets Drug: Lamictal® 25 mg Chewable Tablets |
Phase | Phase 1 |
Sponsor | Teva Pharmaceuticals USA |
Responsible Party | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier | NCT00838279 |
First Received | February 5, 2009 |
Last Updated | September 1, 2009 |
Last verified | September 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | February 5, 2009 |
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Last Updated Date | September 1, 2009 |
Start Date | February 2002 |
Estimated Primary Completion Date | March 2002 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Lamotrigine 25 mg Chewable Tablets, Fasting |
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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 Fasting Conditions |
Brief 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 fasting conditions. |
Detailed Description | Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label |
Condition | Healthy |
Intervention | Drug: Lamotrigine 25 mg Chewable Tablets 2 x 25 mg, single-dose fasting Drug: Lamictal® 25 mg Chewable Tablets 2 x 25 mg, single-dose fasting |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 32 |
Estimated Completion Date | March 2002 |
Estimated Primary Completion Date | March 2002 |
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 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00838279 |
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Other Study ID Numbers | 01303 |
Has Data Monitoring Committee | No |
Information Provided By | Teva Pharmaceuticals USA |
Study Sponsor | Teva Pharmaceuticals USA |
Collaborators | Not Provided |
Investigators | Principal Investigator: Eric Bicrell, M.D. Anapharm |
Verification Date | September 2009 |
Locations[ + expand ][ + ]
Anapharm Inc. | Sainte-Foy, Quebec, Canada, GIV2K8 |
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