A Phase 1, Open-label, Cross-over Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine Following Single Dose Oral Administration of KT110 Tablet and Following Administration of Alpress and Periactin Marketed Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. Subjects will be randomized to the following sequences:
(A) Period 1: KT110 - wash-out period - Period 2: Alpress and Periactin marketed tablets ; Or (B) Period 1: Alpress and Periactin marketed tablets - wash-out period - Period 2: KT110
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male/female subject
- •Females of childbearing potential and male participant must agree to use an adequate and highly effective method of contraception
- •Negative serum pregnancy test at screening for woman of childbearing potential only
- •Non-smoker subject or smoker of not more than 5 cigarettes a day
- •Body Mass Index (BMI) between 18.5 and 30 kg/m2 inclusive, at screening
排除标准
- •Any contraindication to Prazosin or Cyproheptadine treatments;
- •Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
- •Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease equal to or greater than 20 mmHg in systolic blood pressure (SBP) and a decrease equal to or greater than 10 mmHg in diastolic blood pressure (DBP) within two minutes of changing from supine to standing position;
- •Blood donation (including as part of a clinical trial) in the 2 months before administration
- •Any drug intake (except paracetamol or contraception) during the month prior to the first administration;
- •History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day)
- •Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day);
- •Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
- •Positive results of screening for drugs of abuse
研究组 & 干预措施
KT110
Subjects will be randomized to receive KT110 on period 1 or period 2
干预措施: KT110 (Drug)
Prazosin + cyproheptadine
Subjects will be randomized to receive prazosin + cyproheptadine on period 1 or period 2
干预措施: Prazosin + cyproheptadine (Drug)
结局指标
主要结局
Cmax
时间窗: Day 4
Maximum observed concentration
AUC (area under the curve) 0-t
时间窗: Day 4
Area under the curve from time 0 to the last measurable concentration at time t
AUC 0-inf
时间窗: Day 4
Area under the curve from time 0 extrapolated to infinity (only for Cyproheptadine)
Tmax
时间窗: Day 4
Time of maximum observed concentration
T1/2
时间窗: Day 4
Apparent elimination half-life
K el
时间窗: Day 4
Apparent Elimination rate constant
次要结局
未报告次要终点