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

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ClinicalTrials.gov Identifier: NCT02603770
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Lipid Metabolism Disorder Drug: XueZhiKang Drug: Lovastatin Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: XueZhiKang (XZK)
XueZhiKang (XZK) 1200 mg
Drug: XueZhiKang
Other Name: XZK

Active Comparator: Lovastatin
Lovastatin 20 mg
Drug: Lovastatin
Other Name: Mevacor




Primary Outcome Measures :
  1. AUC for the Pharmacokinetics (PK) of XZK [ Time Frame: 12 days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603770


Locations
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United States, California
NRC Research Institute
Orange, California, United States, 92868
Sponsors and Collaborators
Luye Pharma Group Ltd.
Investigators
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Study Chair: Simon LI, M.D. Luye Pharma
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Responsible Party: Luye Pharma Group Ltd.
ClinicalTrials.gov Identifier: NCT02603770    
Other Study ID Numbers: LY02405/CT-USA-102
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Metabolic Diseases
Lipid Metabolism Disorders
Lovastatin
L 647318
Dihydromevinolin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors