Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions

Completed · Not applicable

Conditions studied: Intermittent Claudication

In brief

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.

Key facts

Study ID

NCT00602173

Run by

Roxane Laboratories

People needed

32

Starts

2003-05-01

Expected to finish

2003-05-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• CEDRA Clinical Research, LLC — Austin, Texas, United States

Full record on ClinicalTrials.gov

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