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Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions

NCT00835263 · 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 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Lamotrigine

200 mg Tablet

DRUG

Lamictal®

200 mg Tablet

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Benoit Girard, MD · Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2002-02-28
Completion
2002-02-28

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 NCT00835263 on ClinicalTrials.gov