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

NCT ID: NCT01455558

Last Updated: 2011-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-09-30

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.

Conditions

Healthy

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cilostazol

Group Type: EXPERIMENTAL

Pletaal

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyungsoo Park

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 22129569 (View on PubMed)

Other Identifiers

PCF_PP-101

Identifier Type: -

Identifier Source: org_study_id