Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions
Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intermittent Claudication
Intervention: Cilostazol (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s): Daniel V Freeland, DO, Principal Investigator, Affiliation: CEDRA Clinical Research, LLC
Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol
Tablets, 50 mg, to PLETALŪ Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions
using a single-dose, randomized, 2-treatment, 2-period, crossover design.
Clinical Details
Official title: A Single Dose, Randomized, Two-Period, Two-Treatment, Crossover Bioequivalency Study of Cilostazol 50 mg Tablets Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
CEDRA Clinical Research, LLC, Austin, Texas 78759, United States
Additional Information
Starting date: February 2004
Last updated: January 31, 2008
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