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Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed Condition

2014-08-27 03:12:18 | BioPortfolio

Summary

The objective of this study is to compare the rate and extent of absorption of nateglinide 120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under fed conditions.

Description

Single center, bioequivalence, open-label, randomized, 2-way crossover study. 54 + 4 healthy adult male or female, smokers and/or non-smokers. Single oral dose (1 x 120 mg) in each period with a washout of at least 7 days between doses. Dosing with 240 ml of glucose solution (25%).

Study Design

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

Conditions

Healthy

Intervention

Nateglinide

Status

Completed

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:18-0400

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The objective of this study is to compare the rate and extent of absorption of nateglinide 120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under fasti...

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