Skip to main content
OpenTrials
Completed

NCT Number: NCT01876797

PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male aged 19 - 45 years at screening visit
  • body weight at least 60 kg at screening visit
  • body mass index 18 - 30 kg/m2
  • SBP 90 - 149 mmHg and DBP 60 - 99 mmHg and pulse rate(beat per minute) 45 - 100 at screening visit

Exclusion criteria

  • any history of or having any clinically significant abnormalities
  • any gastrointestinal disorder having impact on absorption of study drug
  • any history of hypersensitivity of ticagrelor or prasugrel or compounds related study drugs
  • any history of taking original medicines within 30 days before dosing or history of taking prescribed drug within 14 days before dosing or history of taking OTC drug within 7 days before dosing
  • any history of taking other study drug within 60 days before dosing
  • any history of whole blood transfusion within 60 days before dosing or history of blood elements transfusion or history of heaving been transfused within 30 days before 30 days
  • any history of taking metabolic inducer or inhibitor
  • overuse (caffeine: > 5 units/day , alcohol: > 21 units /week, smoking: > 10 cigarettes/day)
  • positive serology testy(Hbs antigen, HIV, Hepatitis C virus, Syphilis)
  • any abnormality in clinical laboratory tests result or any ECG finding considered to be inadequate by investigator

Treatment and study plan

ticagrelor/prasugrel

Drug

Other names: ticagrelor :2 tablets of Brilinta® 90 mg, prasugrel : 6 tablets of Effient® 10 mg

Primary outcomes

  1. plasma ticagrelor parent,AR-C124910XX,R-95913 and R-13727

    Time frame: 0,10 min,15 min,25 min,0.5h,1h,1.5h,2h,2.5h,4h,6h,8h,12h and 24h

    4 mL of blood will be drawn per each collection

Secondary outcomes

  1. Maximal Platelet Aggregation(MPA)

    Time frame: 0,15 min,0.5 min, 1h,2h,4h,8h and 24h

    platelet aggregation will be tested using light transmission aggregometry

Other outcomes

  1. adverse event monitoring

    Time frame: up to 1 week

    all adverse event will be collected

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

A Single Dose, Open-label, One Sequence, 2-period, Crossover Study to Characterize the Pharmacokinetics and Pharmacodynamics of Ticagrelor and Prasugrel in Healthy Male Adult Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2013
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.