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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA); Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881231

AA17524

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

1

Experimental group

Description:

Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)

Treatment:

Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)

2

Active Comparator group

Description:

Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)

Treatment:

Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)