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

NCT ID: NCT02603770

Last Updated: 2016-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-02-29

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.

Conditions

Lipid Metabolism Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XueZhiKang (XZK)

XueZhiKang (XZK) 1200 mg

Group Type: EXPERIMENTAL

XueZhiKang

Intervention Type: DRUG

Lovastatin

Lovastatin 20 mg

Group Type: ACTIVE_COMPARATOR

Lovastatin

Intervention Type: DRUG

Interventions

XueZhiKang

Intervention Type: DRUG

Lovastatin

Intervention Type: DRUG

Other Intervention Names

XZK; Mevacor

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon LI, M.D.

Role: STUDY_CHAIR

Luye Pharma

Locations

NRC Research Institute

Orange, California, United States

Countries

United States

Other Identifiers

LY02405/CT-USA-102

Identifier Type: -

Identifier Source: org_study_id