DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Bioequivalency Study of 100 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, 100 mg, to PLETALŪ Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.

Clinical Details

Official title: A Single Dose, Randomized, Three-Period, Three-Treatment, Crossover Bioequivalency Study of Cilostazol 100 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: May 2003
Last updated: January 31, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017