Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions

• Sponsor: Roxane Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00602173
• Collaborator: (none)
• Enrollment: 32
• Location: 1

Study Details

Study Description

Brief Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Claudication	Drug: Cilostazol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Dose, Randomized, Three-Period, Three-Treatment, Crossover Bioequivalency Study of Cilostazol 100 mg Tablets Under Fasting Conditions
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: May 1, 2003
• Actual Study Completion Date: May 1, 2003

Outcome Measures

Primary Outcome Measures

1. Bioequivalence [Baseline, Two period, Seven day washout]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

• Positive test for HIV, Hepatitis B, or Hepatitis C.

• Treatment with known enzyme altering drugs.

• History of allergic or adverse response to Cilostazol or any comparable or similar product.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CEDRA Clinical Research, LLC	Austin	Texas	United States	78759

Sponsors and Collaborators

• Roxane Laboratories

Investigators

• Principal Investigator: Daniel V Freeland, DO, CEDRA Clinical Research, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00602173
• Other Study ID Numbers: CILO-03
• First Posted: Jan 28, 2008
• Last Update Posted: Jan 23, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Intermittent Claudication; Cilostazol

Study Results

No Results Posted as of Jan 23, 2018