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Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions

NCT06199791 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-10

No results posted yet for this study

Summary

To assess the bioequivalence of lamotrigine from Lamotrigin Desitin 100 mg tablets and Lamictal 100 mg Tablet.

Conditions

  • Fasting

Interventions

DRUG

Lamotrigine 100 MG

tablets

Sponsors & Collaborators

  • BioPharma Services Inc.

    collaborator INDUSTRY

  • Desitin Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Janice Faulknor, MD · BioPharma Services Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2023-05-09
Completion
2023-06-14

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 NCT06199791 on ClinicalTrials.gov