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
Overview
- Phase
- Phase 1
- Intervention
- HGP0816
- Conditions
- Primary Hypercholesterolemia
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 60
- Primary Endpoint
- AUClast of Free Ezetimibe
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group1
C → A + B A : HGP0816 B : HGP1404 C : HCP1306
Intervention: HGP0816
Group1
C → A + B A : HGP0816 B : HGP1404 C : HCP1306
Intervention: HGP1404
Group1
C → A + B A : HGP0816 B : HGP1404 C : HCP1306
Intervention: HCP1306
Group2
A + B → C A : HGP0816 B : HGP1404 C : HCP1306
Intervention: HGP0816
Group2
A + B → C A : HGP0816 B : HGP1404 C : HCP1306
Intervention: HGP1404
Group2
A + B → C A : HGP0816 B : HGP1404 C : HCP1306
Intervention: HCP1306
Outcomes
Primary Outcomes
AUClast of Free Ezetimibe
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)