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Lamotrigine 25 mg Chewable Tablets, Fasting

NCT00838279 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-08-19

Study results available
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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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Eric Bicrell, M.D. · Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2002-03-31
Completion
2002-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838279 on ClinicalTrials.gov