Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: HGP0816; Drug: HGP1404; Drug: HCP1306

• Registration Number: NCT02941848
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to evaluate Pharmacokinetic Properties and Safety after administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in the healthy adults.

Detailed Description

A Randomized, Open-Label, Two-way Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety after administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in the healthy adults

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Study First Posted: 2016-10-21
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group2	HGP1404	A + B → C A : HGP0816 B : HGP1404 C : HCP1306
Group2	HCP1306	A + B → C A : HGP0816 B : HGP1404 C : HCP1306
Group1	HGP1404	C → A + B A : HGP0816 B : HGP1404 C : HCP1306
Group1	HCP1306	C → A + B A : HGP0816 B : HGP1404 C : HCP1306
Group2	HGP0816	A + B → C A : HGP0816 B : HGP1404 C : HCP1306
Group1	HGP0816	C → A + B A : HGP0816 B : HGP1404 C : HCP1306

Primary Outcome Measures

Name	Time	Method
AUClast of Free Ezetimibe	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
Cmax of Free Ezetimibe	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
AUClast of Rosuvastatin	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
Cmax of Rosuvastatin	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours

Secondary Outcome Measures

Name	Time	Method
AUCinf of Rosuvastatin	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
CL/F of Rosuvastatin	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
AUCinf of Free Ezetimibe	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
Tmax of Free Ezetimibe	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
Vd/F of Free Ezetimibe	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
CL/F of Free Ezetimibe	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
tmax of Rosuvastatin	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
t1/2 of Rosuvastatin	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
Vd/F of Rosuvastatin	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
MRT of Rosuvastatin	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
T1/2 of Free Ezetimibe	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours
MRT of Free Ezetimibe	Pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96 hours