Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers
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ClinicalTrials.gov Identifier: NCT01455558 |
Recruitment Status
:
Completed
First Posted
: October 20, 2011
Last Update Posted
: October 20, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Pletaal | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Cilostazol |
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 |
- Profile of Pharmacokinetics [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose for test drug; 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36, 48, 72 hours post-dose for reference drug ]Cmax, Area Under Curve

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Ages Eligible for Study: | 19 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male or female volunteers between the ages of 19 and 55 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
- Female subjects showing positive results on a serum pregnancy test before the study, and those who were of childbearing potential agreed to use one of the following medically accepted methods of contraception during the entire period of the study: abstinence, documented tubal ligation at least 1 year before enrollment in the study, documented placement of an intrauterine device with a proven failure rate of <1% per year, or double barrier methods (a spermicide plus a male condom or female diaphragm).
Exclusion Criteria:
- History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
- Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
- Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
- Use of any substance that could induce CYP3A4 synthesis (eg, St. John's wort, other herbal medications).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455558
Korea, Republic of | |
Severance Hospital | |
Seoul, Korea, Republic of, 120-752 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kyungsoo Park, Associate Professor, Severance Hospital |
ClinicalTrials.gov Identifier: | NCT01455558 History of Changes |
Other Study ID Numbers: |
PCF_PP-101 |
First Posted: | October 20, 2011 Key Record Dates |
Last Update Posted: | October 20, 2011 |
Last Verified: | October 2011 |
Keywords provided by Kyungsoo Park, Severance Hospital:
Pharmacokinetics |
Additional relevant MeSH terms:
Cilostazol Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Fibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Vasodilator Agents Neuroprotective Agents Protective Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors |