NCT02603770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

November 10, 2015

Last Update Submit

December 2, 2016

Conditions

Lipid Metabolism Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

XueZhiKang (XZK)

EXPERIMENTAL

XueZhiKang (XZK) 1200 mg

Drug: XueZhiKang

Lovastatin

ACTIVE COMPARATOR

Lovastatin 20 mg

Drug: Lovastatin

Interventions

XueZhiKangDRUG
Also known as: XZK
XueZhiKang (XZK)
LovastatinDRUG
Also known as: Mevacor
Lovastatin

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NRC Research Institute

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Interventions

xuezhikangLovastatin

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Simon LI, M.D.

    Luye Pharma

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 13, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

December 5, 2016

Record last verified: 2016-12

Locations

US(1)