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Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition

NCT01131975 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-06-14

No results posted yet for this study

Summary

The purpose of this study is to determine the pharmacokinetics and bioequivalence of Lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions

Conditions

  • Healthy

Interventions

DRUG

Lamotrigine

Lamotrigine Tablets (chewable, dispersible), 25 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Ralph Scallion E.E, M.D. · AAIPharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2003-02-28
Completion
2003-03-31

Countries

  • United States

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 NCT01131975 on ClinicalTrials.gov