JPRN-jRCT2071210099已完成1 期
Phase I clinical study of enarodustat - Bioequivalence study between new drug product and current drug product
Koretomo Ryosuke0 个研究点目标入组 24 人开始时间: 2021年12月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
In the pilot study, lower Cmax of a new drug product compared to a current drug product was observed. The pivotal study was not conducted based on the results of the pilot study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •1. The participant is a healthy Japanese adult male, aged 20 to 45 years, inclusive, at the time of informed consent.
- •2. BMI of at least 18.5 kg/m2 and less than 25.0 kg/m2
排除标准
- •1. Clinically relevant history or current treatment of serious disease such as cerebral, hepatic, renal, cardiac, pulmonary, gastrointestinal, hematological, endocrine, metabolic or psychiatric disease
- •2. Found to meet protocol-defined conditions determined by screening results (e.g., laboratory tests, vital sign)
- •3. Positive SARS-CoV-2 test result
- •4. History of gestrointestinal surgery that would be expected to influence the absorption of drugs.
- •5. History or presence of any drug allergy
- •6. History or presence of drug or alcohol abuse
研究者
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