NCT03765944已完成1 期
A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults
Nobelpharma1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年12月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Blood sirolimus concentration
研究概览
简要总结
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy subjects aged 20 to 39 years of age
- •Subjects with BMI ≥ 18.5 kg/m2 and < 25.0 kg/m2
- •Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening
- •Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration
- •Subjects who write informed consent
- •Subjects who are able to comply with the study requirements during the study period
排除标准
- •Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative
- •Subjects who have a history of hypersensitivity or allergies to other drug
- •SUbjects who have an acute or chronic infectious diseases
- •Subjects who have a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments
- •Subjects who have diagnosed with alcoholism or a history of alcoholism
- •Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at screening
- •Subjects who have been administered other investigational drug within 12 weeks before the initial administration
- •Subjects who have performed blood collection or donation as follows
- •Collected or donated 200 ml or more whole blood within 4 weeks before the initial administration
- •Male subject; collected or donated more than 400 mL whole blood within 12 weeks before the initial administration
- •Female subjects; collected or donated more than 400 mL whole blood within 16 weeks before the initial administration
- •Collected or donated blood component within 2 weeks before the initial administration
- •Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, or syphilis
- •Subjects who received any non-prescription or prescription drug within 12 weeks before the initial administration
- •Subjects who are pregnant/lactating, or do not agree to contraception during the period from the screening until 8 weeks after the final administration due to planning to become pregnant
- •Subjects who cannot speak, read and write in Japanese
- •Subjects who are considered by the investigator as unsuitable for participation in the trial
研究组 & 干预措施
NPC-12 granule
Active Comparator
NPC-12 granules (1.0g: 2mg sirolimus)
干预措施: sirolimus (Drug)
NPC-12T tablet
Active Comparator
NPC-12T 2 tablets (2mg sirolimus)
干预措施: sirolimus (Drug)
结局指标
主要结局
Blood sirolimus concentration
时间窗: Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)
Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSCTuberous Sclerosis ComplexNCT05495425Nobelpharma43
已完成
1 期
Repeated dose study of NPC-22SialorrheaJPRN-jRCT2031210169Miyoshi Katsunori16
已完成
1 期
A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy SmokersTobacco Use DisorderNCT03541044GlaxoSmithKline46
已完成
3 期
Long-term Trial of Topical Sirolimus to Angiofibroma in Patient With Tuberous Sclerosis ComplexTuberous SclerosisHypomelanotic MaculePlaqueAngiofibromaNCT02634931Nobelpharma94
已完成
1 期
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fed ConditionsHealthyNCT01634399Torrent Pharmaceuticals Limited