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



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:November 2015
End Date:February 2016

Use our guide to learn which trials are right for you!

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.

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.

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).
We found this trial at
1
site
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials