Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Healthy |
| Intervention | Drug: Lamotrigine Drug: Lamictal® |
| Phase | Phase 1 |
| Sponsor | Teva Pharmaceuticals USA |
| Responsible Party | Teva Pharmaceuticals USA |
| ClinicalTrials.gov Identifier | NCT00835263 |
| First Received | January 30, 2009 |
| Last Updated | September 1, 2009 |
| Last verified | September 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 30, 2009 |
|---|---|
| Last Updated Date | September 1, 2009 |
| Start Date | January 2002 |
| Estimated Primary Completion Date | February 2002 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions |
|---|---|
| Official Title | Randomized, 2-Way, Crossover, Bioequivalence Study of Lamotrigine 200 mg Tablets and Lamictal® 200 mg Tablets Administered as 1 x 200 mg Tablet in Healthy Subjects Under Fed Conditions |
| Brief 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. |
| 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 200 mg Tablet Drug: Lamictal® 200 mg Tablet |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 32 |
| Estimated Completion Date | February 2002 |
| Estimated Primary Completion Date | February 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, - 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). |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00835263 |
|---|---|
| Other Study ID Numbers | 01306 |
| Has Data Monitoring Committee | No |
| Information Provided By | Teva Pharmaceuticals USA |
| Study Sponsor | Teva Pharmaceuticals USA |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Benoit Girard, MD Anapharm |
| Verification Date | September 2009 |
Locations[ + expand ][ + ]
| Anapharm Inc. | Sainte-Foy, Quebec, Canada, G1V 2K8 |
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