Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers
This study has been completed.
Sponsor:
Severance Hospital
Information provided by (Responsible Party):
Kyungsoo Park, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01455558
First received: October 14, 2011
Last updated: October 18, 2011
Last verified: October 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Pletaal |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Severance Hospital:
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
| Enrollment: | 92 |
| Study Start Date: | February 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 19 Years to 55 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided by Severance Hospital
Additional 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 |
| Study First Received: | October 14, 2011 |
| Last Updated: | October 18, 2011 |
| Health Authority: | Korea: Food & Drug Administration |
Keywords provided by Severance Hospital:
|
Pharmacokinetics |
Additional relevant MeSH terms:
|
Cilostazol Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Vasodilator Agents Neuroprotective Agents |
Protective Agents Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 17, 2013