Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions

Intermittent Claudication Clinical Trial

Official title:

A Single Dose, Randomized, Three-Period, Three-Treatment, Crossover Bioequivalency Study of Cilostazol 100 mg Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602173
• Other study ID #: CILO-03
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: January 19, 2018
• Start date: May 2003
• Est. completion date: May 2003

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Drug:
• Cilostazol

Locations

Country	Name	City	State
United States	CEDRA Clinical Research, LLC	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two period, Seven day washout