To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA); Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)

• Registration Number: NCT00881231
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Status Verified: 2009-04
• Study First Submitted: 2009-04-13
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)	Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
2	Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)	Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	21 days