Who is sponsoring NCT02603770?

NCT02603770 is sponsored by Luye Pharma Group Ltd..

What condition does NCT02603770 study?

NCT02603770 studies Lipid Metabolism Disorder.

What drugs are being tested in NCT02603770?

Interventions: XueZhiKang, Lovastatin.

What is the status of NCT02603770?

NCT02603770 is currently COMPLETED.

Last reviewed 2016-12-02 · How we verify

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

NCT02603770 Phase 1 COMPLETED

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.

Details

Lead sponsor	Luye Pharma Group Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	20
Start date	2015-11
Completion	2016-02

Conditions

Lipid Metabolism Disorder

Interventions

XueZhiKang
Lovastatin

Primary outcomes

AUC for the Pharmacokinetics (PK) of XZK — 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

Countries

United States