NCT00773630

A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Otsuka Frankfurt Research Institute GmbH · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to test whether Pletal ODT administered without water can be considered bioequivalent to Pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic variables. The secondary objective is to assess the effect of water and the effect of food on the administration of Pletal ODT based on standard pharmacokinetic variables.

Conditions

• Intermittent Claudication

Interventions

Type	Name	Description
DRUG	Cilostazol	100 mg Cilostazol

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-10-16
• Last updated: 2011-09-09

Locations

1 site across 1 country: Germany