JPRN-jRCT2080222725未知1 期
A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Food-Effect of Single Oral Dose Administration of TAK-536TCH Final Formulation Tablet in Healthy Adult Male Subjects
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 24 人开始时间: 2015年1月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 35age old（—）
- 性别
- Male
入选标准
- •1. In the opinion of the investigator and subinvestigator, the participant is capable of understanding and complying with protocol requirements.
- •2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
- •3. The participant is a healthy Japanese adult male.
- •4. The participant is aged 20 to 35 years, inclusive at the time of informed consent.
- •5. The participant weighs at least 50.0 kg and has a body mass index (BMI) from 18.5 to 25.0 kg/m2, inclusive at Screening.
排除标准
- •1. Participant has systolic blood pressure < 90 mmHg at Screening.
- •2. Participant has suspected hypotension and associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on Day -1 of Period 1, or up to administration on the Period 1.
- •3. The participant has received any study drug within 16 weeks (i.e., 112 days) prior to study drug administration of Period 1.
- •4. The participant has received TAK-491*, TAK-536, amlodipine (AML), or hydrochlorothiazide (HCTZ) in a previous clinical study or as a therapeutic agent.
- •*: A prodrug of TAK-536
- •5. Participant has a known hypersensitivity to drugs.
- •6. Participant requires any excluded medication, vitamins, or food products listed in the prohibited medications and foods table.
- •7. Participant has abnormal laboratory values at Screening or prior to study drug administration of Period 1 that suggest a clinically significant underlying disease or participant with the following lab abnormalities: ALT or AST is >1.5-fold of the upper limits of normal range.
- •8. Participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
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