jRCT2071230132已完成不适用
Bioequivalence study of OP-10 in healthy male adults
OHARA Pharmaceutical Co.,Ltd.0 个研究点目标入组 24 人开始时间: 2024年5月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 40age old under（—）
- 性别
- Male
入选标准
- •Healthy Japanese male.
- •Age at the time of obtaining written informed consent is >= 18 to <= 40 years old.
- •BMI at time of screening is >= 18.5 to < 25.
- •Agreement to use contraception and refrain from sperm donation between Day 1 of Period 1 and 180 days after the last dose of study intervention.
- •Written informed consent to participate in this trial can be obtained.
排除标准
- •History of allergy to investigational drug ingredients, drugs, or foods.
- •History of or undergoing treatment for any diseases of respiratory, circulatory, central nervous system, gastrointestinal, hepatic, renal, hematological, or endocrine disorders that affect pharmacokinetics.
- •Other protocol defined exclusion criteria could be applied.
结局指标
主要结局
-
Pharmacokinetics (Cmax, AUC(0-t)) of OP-10
次要结局
未报告次要终点
研究者
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