A Randomized, Open Label, 2-Period, 2-Treatment, Cross-over Phase 1 Study to Evaluate the Bio-equivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Formulation in Healthy Adult Male Subjects
概览
- 阶段
- 1 期
- 干预措施
- TAK-536
- 疾病 / 适应症
- Japanese Healthy Adult Male Participants
- 发起方
- Takeda
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Cmax: Maximum Observed Plasma Concentration for TAK-536
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.
详细描述
The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.
研究者
入排标准
入选标准
- •In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- •Signs and dates a written, informed consent form prior to the initiation of any study procedures.
- •Is a Japanese healthy adult male.
- •Aged 20 to 35 years, inclusive, at the time of informed consent.
- •Weighs at least 50.0 kilogram (kg), and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2), inclusive, at Screening.
排除标准
- •Has suspected hypotension with associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on the day before the study drug administration (Day -1) in Period 1, or up to the study drug administration on the Period
- •Has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period
- •Has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
- •Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- •Has a known hypersensitivity to any component of the formulation of TAK-536 or any angiotensin II receptor blocker (ARB).
- •Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening.
- •Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- •Has taken any excluded medication, supplements, dietary products, or food products during the time periods specified in the protocol.
- •Has any current or recent (within 6 months) gastrointestinal diseases that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention).
- •Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1 of Period
研究组 & 干预措施
TAK-536 Granules + TAK-536 Tablet
TAK-536 10 milligram (mg), granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
干预措施: TAK-536
TAK-536 Tablet + TAK-536 Granules
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
干预措施: TAK-536
结局指标
主要结局
Cmax: Maximum Observed Plasma Concentration for TAK-536
时间窗: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536
时间窗: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
次要结局
- Terminal Disposition Phase Rate Constant (λz) for TAK-536(Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours))
- Number of Participants With TEAEs Related to Vital Signs(Baseline up to Day 6 of Intervention Period 2 (Day 18))
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)(Baseline up to Day 6 of Intervention Period 2 (Day 18))
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536(Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours))
- AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536(Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours))
- MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536(Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours))
- Number of Participants With TEAEs Related to Body Weight(Baseline up to Day 6 of Intervention Period 2 (Day 18))
- Number of Participants With TEAEs Related to Electrocardiograms (ECGs)(Baseline up to Day 6 of Intervention Period 2 (Day 18))
- Number of Participants With TEAEs Related to Clinical Laboratory Tests(Baseline up to Day 6 of Intervention Period 2 (Day 18))