Healthy
Conditions
Keywords
Pharmacokinetics
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.
Interventions
DRUGPletaal
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
Sponsors
Severance Hospital
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Pharmacokinetics | 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 |
Countries
South Korea
Outcome results
None listed