Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers
This study has been completed.
Information provided by (Responsible Party):
Kyungsoo Park, Severance Hospital
First received: October 14, 2011
Last updated: October 18, 2011
Last verified: October 2011
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.
||Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Cmax, Area Under Curve
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2009 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||19 Years to 55 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01455558
|Seoul, Korea, Republic of, 120-752 |
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.
||Kyungsoo Park, Associate Professor, Severance Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 14, 2011
||October 18, 2011
||Korea: Food & Drug Administration
Keywords provided by Severance Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
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