NCT01161979

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

A Randomized. Single-Dose, Two-Way Crossover Relative Bioavailability Study of Zonisamide Formulations in Normal, Healthy Men and Women Following a Standard Meal

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 subjects fed a high standard fat meal.

Detailed description

This was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zonisamide	Zonisamide capsules 100 mg
DRUG	Zonegran	Zonegran Capsules 100 mg of EISAI INC

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-02-01
• Completion: 2005-03-01
• First posted: 2010-07-14
• Last updated: 2010-07-14

Locations

1 site across 1 country: United States