Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers
- Registration Number
- NCT02603770
- Lead Sponsor
- Luye Pharma Group Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description XueZhiKang (XZK) XueZhiKang XueZhiKang (XZK) 1200 mg Lovastatin Lovastatin Lovastatin 20 mg
- Primary Outcome Measures
Name Time Method AUC for the Pharmacokinetics (PK) of XZK 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NRC Research Institute
🇺🇸Orange, California, United States