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.
ConditionHealthy
InterventionDrug: Lamotrigine 25 mg Chewable Tablets
Drug: Lamictal® 25 mg Chewable Tablets
PhasePhase 1
SponsorTeva Pharmaceuticals USA
Responsible PartyTeva Pharmaceuticals USA
ClinicalTrials.gov IdentifierNCT00838279
First ReceivedFebruary 5, 2009
Last UpdatedSeptember 1, 2009
Last verifiedSeptember 2009

Tracking Information[ + expand ][ + ]

First Received DateFebruary 5, 2009
Last Updated DateSeptember 1, 2009
Start DateFebruary 2002
Estimated Primary Completion DateMarch 2002
Current Primary Outcome Measures
  • Cmax - Maximum Observed Concentration [Time Frame: Blood samples collected over 120 hour period] [Designated as safety issue: No]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [Time Frame: Blood samples collected over 120 hour period] [Designated as safety issue: No]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [Time Frame: Blood samples collected over 120 hour period] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleLamotrigine 25 mg Chewable Tablets, Fasting
Official TitleRandomized, 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 TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionHealthy
InterventionDrug: 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)
  • Experimental: Lamotrigine
    Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
  • Active Comparator: Lamictal®
    Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment32
Estimated Completion DateMarch 2002
Estimated Primary Completion DateMarch 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesCanada

Administrative Information[ + expand ][ + ]

NCT Number NCT00838279
Other Study ID Numbers01303
Has Data Monitoring CommitteeNo
Information Provided ByTeva Pharmaceuticals USA
Study SponsorTeva Pharmaceuticals USA
CollaboratorsNot Provided
Investigators Principal Investigator: Eric Bicrell, M.D. Anapharm
Verification DateSeptember 2009

Locations[ + expand ][ + ]

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