NCT01455558已完成1 期
Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Profile of Pharmacokinetics
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
Cilostazol
Experimental
干预措施: Pletaal (Drug)
结局指标
主要结局
Profile of Pharmacokinetics
时间窗: 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
次要结局
未报告次要终点
研究者
Kyungsoo Park
Associate Professor
Severance Hospital
研究点 (1)
Loading locations...
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