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

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

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.

Study Overview

• Status: Completed
• Conditions: Lipid Metabolism Disorder
• Intervention / Treatment: Drug: Lovastatin; Drug: XueZhiKang

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • NRC Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XueZhiKang (XZK); XueZhiKang (XZK) 1200 mg	Drug: XueZhiKang; Other Names: XZK
Active Comparator: Lovastatin; Lovastatin 20 mg	Drug: Lovastatin; Other Names: Mevacor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.
• Investigators: Study Chair: Simon LI, M.D., Luye Pharma

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lovastatin; L 647318; Dihydromevinolin
• Other Study ID Numbers: LY02405/CT-USA-102