JPRN-jRCT2071210085已完成1 期
Clinical pharmacology study of K-237 in healthy adult volunteers
Tanigawa Ryohei0 个研究点目标入组 23 人开始时间: 2021年10月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
研究概览
简要总结
Plasma IVM B1a (unchanged Ivermectin) concentration after K-237 administration can be affected by food. No clinically relevant adverse events or side effects were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 40age old（—）
- 性别
- All
入选标准
- •(1) Subject is a healthy adult volunteer.
- •(2) Subject is between the ages of 20 and 40 years at the time of signing informed consent.
- •(3) Subject has a body mass index of 17.6 to 26.4 kg/m2 at Screening.
排除标准
- •(1) Subject has a supine blood pressure after resting for at least 5 minutes that is lower than 90 mmHg systolic or higher than 140 mmHg systolic, and lower than 40 mmHg diastolic or higher than 90 mmHg diastolic at Screening.
- •(2) Subject has used a drug (including over-the-counter drug) within 14 days before the administration of the study drug or a supplement within 4 weeks before the administration of the study drug, or those who need to use it during the study period.
- •(3) Subject has a current malabsorption, and those who had an operation on the gastrointestinal tract that may affect absorption (excluding appendectomy and treatment for hernia).
研究者
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