JPRN-jRCT1080222790已完成Unknown
Bioequivalence study of OPC-41061 1% powder-formulation
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 61
研究概览
简要总结
The bioequivalence of OPC-41061 1% powder and OPC-41061 15-mg tablet was demonstrated. There were no safety problems with either formulation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 39age old（—）
- 性别
- Male
入选标准
- •1)Judged to be capable of providing written informed consent prior to the start of the examinations for this study
- •2)Body weight of at least 50.0 kg
- •3)BMI [body weight in kg / (height in m)2]: At least 17.6 kg/m2 and less than 25.0 kg/m2
- •4)Judged to be healthy based on medical history, physical findings, vital signs, 12-lead ECG, clinical laboratory findings, etc
- •5)Subjects who, together with their partner(s), are capable of using an effective method of contraception from the time of written informed consent until 90 days after final investigational medicinal product (IMP) administration
排除标准
- •1)Abnormality that could place the subject at risk or affect drug absorption, distribution, metabolism, or excretion; includes history or current symptoms of cardiac, hepatic, renal, neurological, endocrine, gastrointestinal, respiratory, hematological, or immunological disease
- •2)History of alcohol or drug dependence or abuse
- •3)Suspected infection with hepatitis B, hepatitis C, HIV, or syphilis based on results of the respective tests
- •4)History of any drug allergy (including all prescription and OTC drugs)
- •5)Urine alcohol test result of 0.1 mg/mL or more or positive result for urine drug screening
- •6)History of difficulty in blood collection
- •7)Administration of any investigational drug within 120 days prior to Period 1 IMP administration
- •8)Blood collection (blood donation, etc) of more than 200 mL within 30 days, more than 400 mL within 90 days, or 1200 mL or more within 1 year prior to Period 1 IMP administration
- •9)Consumption of any food or beverage containing St. John's wort within 14 days prior to Period 1 IMP administration
- •10)Consumption of any food or beverage containing grapefruit, Seville orange, or star fruit within 7 days prior to Period 1 IMP administration
- •11)Use of any prescription or OTC drug within 14 days prior to Period 1 IMP administration
- •12)Smoking or positive result for urine cotinine test within 60 days prior to Period 1 IMP administration
- •13)Occupational exposure to pesticides or organic solvents within 30 days prior to screening
- •14)Blood pressure after 3 minutes of rest outside the normal range at the study site
- •15)Heart rate after 3 minutes of rest outside the normal range at the study site
- •16)History of bleeding or bleeding tendency
- •17)No fixed address
- •18)History of any serious psychiatric disorder judged inappropriate for inclusion in the study
研究者
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