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Evaluation of drug-drug interaction between cytochrome P450 substrate Selexipag and Clopidogrel in human

Evaluation of drug-drug interaction between cytochrome P450 substrate Selexipag and Clopidogrel in human - Drug-drug interaction between Selexipag and Clopidogrel

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032266
Enrollment
15
Registered
2018-04-16
Start date
2018-05-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pharmacokinetic trial

Interventions

In 1st pharmacokinetic(PK) trial, subjects take selexipag 0.4mg at 0 min, and physicians take blood samples at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours. 3 days before 2nd PK trial, subjects take c

Sponsors

Hamamatsu University School of Medicine, Clinical Pharmacology and Therapeutics
Lead Sponsor
School of Pharmaceutical Sciences Univercity of shizuoka, Department of Pharmacy Practice and Science
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1 over 20 years-old male 2 subject who has no abnormality of hemglobin value and platelet count 3 subject who has no liver dysfunction, renal dysfunction and disease receiving treatment 4 subject who has no drug allergy and idiosyncrasy 5 subject who has no dependence of drug and alcohol 6 subject who can provide imformed consent

Exclusion criteria

Exclusion criteria: 1 subject who takes medicine 1 week before each 1st and 2nd PK trial 2 subject who has apparent abnormality in advance blood and biochemical examinations 3 subject who were judged to be not eligible in this study by the physician in chrage

Design outcomes

Primary

MeasureTime frame
AUC 0 to 48hrs and 0 to infinity of Selexipag and MRE 269

Countries

Japan

Contacts

Public ContactAkio Hakamata

Hamamatsu University School of Medicine Clinical Pharmacology and Therapeutics

hakamata@hama-med.ac.jp053-435-2385

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026