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The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared With Lamotrigine Compressed Tablet 25mg in Chinese Healthy Male Subjects

NCT01879423 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-06-01

No results posted yet for this study

Summary

This is a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed tablets (25mg) in healthy Chinese male subjects in fasting conditions. The safety, tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will also be assessed.

Conditions

Interventions

DRUG

Lamotrigine Dispersible/Chewable tablets 5mg*5

Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg\*1 tablet at Day15

DRUG

Lamotrigine Compressed tablet 25mg

Single dose of lamotrigine compressed 25mg\*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day15

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-04-28
Primary Completion
2013-06-06
Completion
2013-06-06

Countries

  • China

Study Locations

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Entities

Diseases
Companies

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 NCT01879423 on ClinicalTrials.gov