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

2014-08-27 03:13:22 | BioPortfolio

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 volunteers under fasted conditions.

Description

A single-dose, two-way, bioequivalence study in up to 26 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of Lamotrigine chewable dispersible formulations under fasted conditions.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Lamotrigine

Location

AAI Clinic
Chapel Hill
North Carolina
United States
27514

Status

Completed

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:22-0400

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