A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan
研究概览
简要总结
To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight of at least 50.0 kg
- •BMI [body weight in kg / (height in m)2] of at least 17.6 kg/m2 and less than 25.0 kg/m2
- •Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to the start of any trial-related procedures and capable of complying with the trial procedures for this study.
排除标准
- •Judged by the investigator,subinvestigator, or sponsor to have a clinically significant abnormality in results of the screening examination (including a notable deviation from the site's standard values) or a medical history that could place the subject at risk or affect the evaluation of drug absorption, distribution, metabolism, or excretion
- •History of alcohol or drug dependence or abuse within 2 years prior to the trial
- •History or current infection with hepatitis or acquired immunodeficiency syndrome (AIDS) or carrier of hepatitis B positive surface antigen (HBsAg), anti-hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis based on the results of the Treponema pallidum (TP) antibody test or rapid plasma reagin (RPR) test
- •History of any severe drug allergy
- •Positive results in alcohol screening test or urine drug screening test at time of screening examination or trial site admission
- •Use of any other investigational medicinal product (IMP) within 120 days prior to Period 1 IMP administration
- •Consumption of any food or beverage containing St. John's wort within 14 days prior to Period 1 IMP administration
- •Consumption of any food or beverage containing grapefruit, Seville orange, or star fruit within 7 days prior to Period 1 IMP administration
- •Judgment by the investigator or subinvestigator that the subject should not participate in the study for any other reason.
研究组 & 干预措施
OPC41061(15 mg) disintegrating tablet with water
OPC41061 (15 mg) orally disintegrating tablet is administered with water.
干预措施: OPC-41061 (Drug)
OPC-41061(15 mg) disintegrating tablet without water
OPC41061 (15 mg) orally disintegrating tablet is administered without water.
干预措施: OPC-41061 (Drug)
OPC-41061(15 mg) conventional tablet with water
OPC-41061 (15 mg) conventional tablet is administered with water.
干预措施: OPC-41061 (Drug)
OPC41061(30 mg) disintegrating tablet with water
OPC41061 (30 mg) orally disintegrating tablet is administered with water.
干预措施: OPC-41061 (Drug)
OPC-41061(30 mg) disintegrating tablet without water
OPC41061 (30 mg) orally disintegrating tablet is administered without water.
干预措施: OPC-41061 (Drug)
OPC-41061(30 mg) conventional tablet with water
OPC-41061 (30 mg) conventional tablet is administered with water.
干预措施: OPC-41061 (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan
时间窗: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose
Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation.
Maximum Plasma Concentration (Cmax) of Tolvaptan
时间窗: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose
Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation.
次要结局
未报告次要终点