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

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02603770
Study type Interventional
Source Luye Pharma Group Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 2015
Completion date February 2016
View Details
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