NCT00881231

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_1 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
Last Updated

March 28, 2017

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

April 13, 2009

Last Update Submit

March 27, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    21 days

Study Arms (2)

1

EXPERIMENTAL

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

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

2

ACTIVE COMPARATOR

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

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

Interventions

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

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

CilostazolLong-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gaetano Morelli, M.D.

    MDS Pharma Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 15, 2009

Study Start

January 1, 2004

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

March 28, 2017

Record last verified: 2009-04