Lipid Metabolism Disorder
Conditions
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.
Interventions
DRUGXueZhiKang
DRUGLovastatin
Sponsors
Luye Pharma Group Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed