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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Pletaal	Phase 1

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Severance Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee D, Lim LA, Jang SB, Lee YJ, Chung JY, Choi JR, Kim K, Park JW, Yoon H, Lee J, Park MS, Park K. Pharmacokinetic comparison of sustained- and immediate-release oral formulations of cilostazol in healthy Korean subjects: a randomized, open-label, 3-part, sequential, 2-period, crossover, single-dose, food-effect, and multiple-dose study. Clin Ther. 2011 Dec;33(12):2038-53. doi: 10.1016/j.clinthera.2011.10.024. Epub 2011 Nov 29.

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
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