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
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 |
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.
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). |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | NRC Research Institute | Orange | California |
Lead Sponsor | Collaborator |
---|---|
Luye Pharma Group Ltd. |
United States,
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 |
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