A Randomized, Open-label, Multiple-dose, Two-period, Crossover, Study to Investigate the Pharmacokinetic Profile of 2 Formulations of JKB-122 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 主要终点
- Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬)
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.
详细描述
This clinical study will be a randomized, open-label, multiple-dose, two-period, crossover study in healthy male subjects. After screening, subjects will be randomized to receive either JKB-122 tablet or JKB-122 capsule in a 1:1 ratio. There will be two dosing periods (Period 1 and Period 2). Subjects who receive JKB-122 capsule during Period 1 will receive JKB-122 tablet during Period 2 and vice versa. The 2 dosing periods will be separated by a washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The subject has a body mass index (BMI) range of 18.5 and < 25.0 kg/m2 and weighs at least 50 kg.
- •Agreement for subject and female partner of childbearing potential to use acceptable method of contraception
- •The subject provided written informed consent.
排除标准
- •Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
- •Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
- •Use of prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration.
- •Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration.
- •Current smoker or history of smoking within 3 months before the Screening Visit.
- •History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit.
- •Any use of drugs-of-abuse within 3 months before the Screening Visit.
- •Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration.
- •Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus.
- •Participation in any clinical study or administration of any investigational product within 1 month of study drug administration.
- •The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.
研究组 & 干预措施
Capsule
JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2
干预措施: JKB-122 in capsule or tablet form (Drug)
Tablet
JKB-122 tablet on period 1 followed by JKB-122 capsule on period 2
干预措施: JKB-122 in capsule or tablet form (Drug)
结局指标
主要结局
Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬)
时间窗: 2 WEEKS
Plasma PK parameters will be measured comparison between JKB-122 capsule and JKB-122 tablet
次要结局
- Number of Adverse events (AEs) observed(2 WEEKS)