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Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition

NCT01888250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-06-27

No results posted yet for this study

Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.

Conditions

  • Healthy

Interventions

DRUG

Lamotrigine

Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Srinivas Yadav K, Dr. · Bioserve Clinical Research Private Limited,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • India

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 NCT01888250 on ClinicalTrials.gov