NCT02603770已完成1 期
A Single Site, Randomized Open Label Cross-Over Study to Compare Pharmacokinetic Profiles (PK) of XueZhiKang (XZK) Capsules Versus Lovastatin Tablets in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC for the Pharmacokinetics (PK) of XZK
研究概览
简要总结
The objective of this study is to compare laboratory tests profiles of a botanic drug XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy male volunteers between 18 and 50 years of age.
详细描述
Twenty (20) healthy male subjects will be enrolled and assigned to either XZK group or Lovastatin group at a 1:1 ratio at one site in the USA.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Capable of giving informed consent and complying with study procedures;
- •Male subjects between the ages of 18 and 50 years, inclusive;
- •Considered healthy by the PI, based on a detailed medical history, physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
- •Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;
- •Body Mass Index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 mg;
- •Willing and able to adhere to study restrictions and to be confined at the clinical research center.
排除标准
- •Clinically significant past history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- •History or presence of malignancy other than adequately treated basal cell skin cancer;
- •Clinically relevant illness within one month prior to the screening visit or at screening visit that may interfere with the conduct of this study;
- •Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C antibody;
- •A history of seizure. However, a history of febrile seizure is allowed;
- •A hospital admission or major surgery within 30 days prior to screening;
- •Participation in any other investigational drug trial within 30 days from the last dosing of other trials to screening;
- •A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
- •A history of alcohol abuse according to medical history within 6 months prior to screening;
- •A positive screen for alcohol, drugs of abuse;
- •Tobacco use within 6 months prior to screening based on subject report;
- •Subjects with hypersensitivity to lipid-lowering agents;
- •Subjects who have participated in a previous clinical study of XZK;
- •An unwillingness or inability to comply with food and beverage restrictions during study participation;
- •Donation or blood collection of more than 1 unit (approximately 450 ml) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
- •Use of prescription or over-the-counter (OTC) medications, and herbal (including St. John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at < 3g/day is permitted until 24 hours prior to dosing).
研究组 & 干预措施
XueZhiKang (XZK)
Experimental
XueZhiKang (XZK) 1200 mg
干预措施: XueZhiKang (Drug)
Lovastatin
Active Comparator
Lovastatin 20 mg
干预措施: Lovastatin (Drug)
结局指标
主要结局
AUC for the Pharmacokinetics (PK) of XZK
时间窗: 12 days
PK Samples drawn at 0 (within 30 minutes prior to dosing), 0.5, 1,2,3,4 (+/- 5 min), 6,8,12 and 24 hour (+/- 15 min) after dosing on Day 1 and Day 11
次要结局
未报告次要终点
研究者
研究点 (1)
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