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NCT00602407 Clinical Trial

Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions

Intermittent Claudication Clinical Trial

Official title:
A Single Dose, Randomized, Two-Period, Two-Treatment, Crossover Bioequivalency Study of Cilostazol 50 mg Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00602407
Other study ID # CILO-05
Secondary ID
Status Completed
Phase N/A
First received January 15, 2008
Last updated January 19, 2018
Start date February 2004
Est. completion date March 2004

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

Clinical Trial Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date March 2004
Est. primary completion date March 2004
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.

Study Design

Related Conditions & MeSH terms

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
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