KCT0005957已完成未知
A single dose, sequence-randomized, open-label, 3x3 crossover study to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo complex product in healthy male subjects
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1.Healthy male volunteers, aged between 20 and 45 years old, with body mass index (BMI) range of 19 to 26 kg/?
- •2.Subjects who are able to collect blood sample during study and able to follow-up visit
- •3.Subjects with vital sign of the following range in sitting.
- •90=Systolic blood pressure(SBP<145(mmHg)
- •60=Diastolic blood pressure(DBP)<90(mmHg)
- •45=Pulse rate=95 (/min)
- •4.Subjects with blood pressure of the following range in the screening test.
- •- Blood pressure: 90=Systolic blood pressure(SBP<145(mmHg), 60=Diastolic blood pressure(DBP)<90(mmHg)
- •- 45=Pulse rate=95 (/min)
- •5.Subjects who are informed of this study, and voluntarily agree to participate in this study and signs informed consent.
排除标准
- •1.Subjects who have a clinically significant past or present medical history of hepato, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, psychiatric, hematologic/neoplastic, and cardiovascular diseases
- •2.Subjects with a history of gastrointestinal disease (e.g. Crone’s disease, ulceration, acute or chronic pancreatitis, etc) or surgery (except simple appendectomy, repair of a hernia), which can influence the absorption of the study drug.
- •3.Subjects with hypersensitivity reactions to drugs like pitavastatin, valsartan or other drug (aspirin, antibiotics, etc.)
- •4.Subjects who have a history of drug abuse or who were positive for the abused drug on urine drug screening
- •5.Subject who used herbal remedies within 30 days prior to the scheduled 1st study drug administration, who used ethical-the-counter drugs within 14 days prior to the scheduled 1st study drug administration and who used over-the-counter drugs within 7 days prior to the scheduled 1st study drug administration (But, subject whose other conditions are judged by investigators as appropriate for this clinical trial could participate in this study.)
- •6.Subject who took Unusual eating(e.g. grapefruit juice (more than 1 L per day) which can influence the absorption, distribution, metabolism, and clearance of the study drug within 14 days prior to the scheduled 1st study drug administration
- •7.Subjects who has participated in any other clinical trial either for investigational or marketed drugs within 90 days prior to the scheduled 1st study drug administration
- •8.Subjects who have donated whole blood within 60 days or any blood products within 30 days prior to the scheduled 1st study drug administration. Also, subjects who receive a blood transfusion within 30 days prior to the scheduled 1st study drug administration
- •9.Subject who took barbiturates or an inducer or inhibitor of drug metabolite enzymes within 30 days before the first study drug administration
- •10.Subjects who excessively drink alcohol or caffeine-containing products or excessively smoke a tobacco products within 3 months prior to the scheduled 1st administration or with a history of alcoholism (caffeine-containing products > 5 units/day, alcohol 21 units/week (1 unit=10 mL as pure alcohol), tobacco products > 10 unit/day)
- •11.Subjects who are positive result of RPR Ab, anti HIV(AIDS), HBs Ag and HCV Ab
- •12.Subjects who are creatinine clearance with Cockroft-Gault = 80 mL/min
- •13.Subjects who with a history of hereditary muscle disorders or family history, or those with a history of muscle disorders caused by drugs
- •14.Subjects who were judged by investigator (or Sub-Investigator) as inappropriate for the clinical trial for abnormality of clinical laboratory examination, electrocardiogram (ECG), and etc. (AST(GOT), ALT(GPT), Total Bilirubin > Upper reference range limit x 1.5)
- •15.Subjects who are scheduled for dental procedure(extraction of a tooth, tooth correction, endodontic treatment, etc.) and elective operation (cosmetic plastic surgery, LASIK(Laser-Assisted In-Situ Keratomileusis), LASEK (Laser-Assisted Sub-Epithelial Keratectomy), etc) until post-study visit after informed.
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