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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Luye Pharma Group Ltd.
• Treatments: Dihydromevinolin; L 647318; Lovastatin

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).