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PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

NCT01876797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-03-03

No results posted yet for this study

Summary

This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and prasugrel in healthy Korean male subjects.

The study is open label, one sequence, crossover design. In period 1, a single oral dose of 180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a single oral dose of 60 mg prasugrel will be administrated.

After dosing each period, blood sampling for PK and PD assessment will be conducted.

1. Blood Sampling Times

1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose
2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose
2. Bioanalysis

1. plasma Ticagrelor
2. plasma AR-C124910XX (active metabolite of ticagrelor)
3. plasma R-95913 (inactive metabolite of prasugrel)
4. plasma R-13727 (active metabolite of prasugrel)
3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)
4. PK-PD Modeling analysis

Conditions

  • Healthy

Interventions

DRUG

ticagrelor/prasugrel

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Hyeong-Seok Lim, Professor · Asan Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01876797 on ClinicalTrials.gov