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

Lipid Metabolism Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603770
• Other study ID #: LY02405/CT-USA-102
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2015
• Last updated: December 2, 2016
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: December 2016
• Source: Luye Pharma Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• XueZhiKang

• Lovastatin

Locations

Country	Name	City	State
United States	NRC Research Institute	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes