Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-357 and D578 in Healthy Volunteers

Phase 1

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: D578; Drug: CKD-357

• Registration Number: NCT03671941
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2018-05-25
• Primary Completion: 2018-06-04
• Study Completion: 2018-06-18
• Status Verified: 2018-09
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	D578	D578 Tab. 1T
Group B	CKD-357	CKD-357 Tab. 1T

Primary Outcome Measures

Name	Time	Method
AUCt 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	Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration
Cmax 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	Maximum plasma concentration of Ticagrelor

Secondary Outcome Measures

Name	Time	Method
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	Time to maximum concentration of of Ticagrelor
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	Apparent terminal half-life of Ticagrelor
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	Area under the plasma concentration of Ticagrelor versus time curve from time zero to time infinity
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	Total body clearance of Ticagrelor
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	Apparent volume of distribution of Ticagrelor
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	Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time of last quantifiable concentration
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	Maximum plasma concentration of AR-C124910XX
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	Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time infinity
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	Time to maximum concentration of AR-C124910XX
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	Apparent terminal half-life of AR-C124910XX

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of