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Orange, California 92868


Purpose:

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 summary:

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.


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).


NCT ID:

NCT02603770


Primary Contact:

Study Chair
Simon LI, M.D.
Luye Pharma


Backup Contact:

N/A


Location Contact:

Orange, California 92868
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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