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Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers

NCT01455558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2011-10-20

No results posted yet for this study

Summary

This study investigates safety and pharmacokinetic comparison of Pacific Pharma's PP-101 SR (test formulation) and Otsuka's Pletaal® IR (reference formulation) for single and multiple doses and food effects on Pacific Pharma's PP-101 SR in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

Pletaal

Part 1: a single dose of the SR (200mg x 1 tablet, QD) and IR (100mg x 2 tablets, BID) formulation of cilostazol orally 7 days apart in a fasted state Part 2: a single dose of the SR (200mg x 1 tablet, QD) formulation of cilostazol 7 days apart in a fasted and a fed state Part 3: multiple doses of the two formulations for eight consecutive days 21 days apart

Sponsors & Collaborators

  • Severance Hospital

    lead OTHER

Study Design

Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455558 on ClinicalTrials.gov