jRCT2071220075已完成不适用
A Phase I Study of Isotretinoin Capsules in Japanese Healthy Adult Male Subjects. (Dose Escalation and Food Effect Studies)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Pharmacokinetics
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
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Basic Science
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 44age old under（—）
- 性别
- Male
入选标准
- •Japanese healthy male adults aged 18 to 44 years or younger
- •Body weight: 55 kg or greater and less than75 kg
- •Body mass index (BMI): 18.5 kg/m2 or greater and less than 25 kg/m2
- •Agreed to implement the contraceptive method described in protocol until 1 month after informed consent is obtained and administration of the investigational product (for part 2, administration in period 2)
排除标准
- •History of allergy or hypersensitivity to isotretinoin, other retinoids or vitamin A, or a history of drug hypersensitivity or intolerance determined by the investigator to be potentially compromising subject or study safety.
- •Significant history (person or family) or current medical history of chronic infection, organ damage or organ dysfunction, particularly cardiovascular disorder (hypertension, etc.), asthma, diabetes mellitus, bone loss (osteoporosis) or bone fragility, anorexia nervosa, liver disorder, or renal disorder.
- •Judged by the investigator to have a history of clinically significant gastrointestinal disease, inflammatory bowel disease, or current disease, or a history of malabsorption within the past year.
- •Concurrent, history, or family history of a psychiatric disorder (depression, psychosis, suicidal ideation, etc.).
- •Current history of medical conditions requiring regular treatment with prescription drugs.
结局指标
主要结局
Pharmacokinetics
Plasma levels of unchanged isotretinoin and three major metabolites and pharmacokinetic parameters of unchanged isotretinoin and major metabolites
Safety
Adverse events, laboratory values, vital signs, and 12-lead ECG
Pharmacokinetics (food effect)
Plasma levels of unchanged isotretinoin and three major metabolites after and after fasting, and pharmacokinetic parameters of unchanged isotretinoin and major metabolites
Safety (food effect)
Adverse events, laboratory values, vital signs, and 12-lead ECG
次要结局
未报告次要终点
研究者
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