JPRN-jRCT1080223416已完成1 期
A Single-center, Open-label, Randomized, 3-Period, 3-Way, Crossover Bioequivalence Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
The bioequivalence of tolvaptan OD tablets and tolvaptan conventional tablet in 15 and 30 mg was demonstrated. There were no safety concerns with either formulation in 2 dosing regimens.
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
- •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.
研究者
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