Clinical trial NCT02603770: Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lipid Metabolism Disorder
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: AUC for the Pharmacokinetics (PK) of XZK
timeFrame: 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: NRC Research Institute
state: California
Study officials:
affiliation: Luye Pharma
name: Simon LI, M.D.
role: STUDY_CHAIR
References: