A Randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetic Profiles and Safety/Tolerability of CKD-357 in Healthy Volunteers

Chong Kun Dang Pharmaceutical1 site in 1 country31 target enrollmentMay 25, 2018

ConditionsAcute Coronary Syndrome

InterventionsD578 CKD-357

DrugsD578 CKD-357

Overview

Phase: Phase 1
Intervention: D578
Conditions: Acute Coronary Syndrome
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 31
Locations: 1
Primary Endpoint: AUCt of Ticagrelor
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, open-label, single dose, crossover study to evaluate pharmacokinetic profiles and safety/tolerability of CKD-357 in healthy volunteers

Detailed Description

To healthy subjects of thirty(30), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Registry

clinicaltrials.gov

Start Date

May 25, 2018

End Date

June 18, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Group A

D578 Tab. 1T

Intervention: D578

Group B

CKD-357 Tab. 1T

Intervention: CKD-357

Outcomes

Primary Outcomes

AUCt of Ticagrelor

Time Frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration

Cmax of Ticagrelor

Time Frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

Maximum plasma concentration of Ticagrelor

Secondary Outcomes

Tmax of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
t1/2 of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
AUCinf of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
CL/F of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
Vd/F of Ticagrelor(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours)
AUCt of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
Cmax of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
AUCinf of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
Tmax of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
t1/2 of AR-C124910XX(Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)