Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lipid Metabolism Disorder

Intervention / Treatment
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* Drug: XueZhiKang
* Drug: Lovastatin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XueZhiKang (XZK)<br>XueZhiKang (XZK) 1200 mg | Drug: XueZhiKang<br> <br> * Other names: XZK;|
| Active Comparator: Lovastatin<br>Lovastatin 20 mg | Drug: Lovastatin<br> <br> * Other names: Mevacor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC for the Pharmacokinetics (PK) of XZK | 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 | 12 days |