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Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions

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

Summary

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in fasted subjects.

Description

This was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fasting conditions. Subjects were confined to the SFBC Clinical Research Facility from at least 10 hours prior to drug administration, until after the 24-hour post-dose blood draw, in each period. The treatment phases were separated by a washout period of 28 days.

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

Zonisamide, Zonegran

Location

SFBC Ft. Myers, Inc.
Fort Myers
Florida
United States
33901

Status

Completed

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

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

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