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

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Eon and Otsuka (Pletal) 50 mg Cilostazol Tablets In Healthy Adults Volunteers Under Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881231

Enrollment

Registered

2009-04-15

Start date

2004-01-31

Completion date

2004-02-29

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	21 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026