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Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition

NCT01618799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-06-13

No results posted yet for this study

Summary

This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.

Conditions

  • Fasting State

Interventions

DRUG

Lamotrigine Tablets 25 mg

2 x 25 mg tablet once a day

DRUG

Lamotrigine

2 x 25 mg tablet once a day

Sponsors & Collaborators

  • IPCA Laboratories Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Manish Singhal, MBBS · Cliantha Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT01618799 on ClinicalTrials.gov