Skip to main content
OpenTrials
Completed

NCT Number: NCT03350386

Drug-drug Interaction Study of FYU-981 and Oxaprozin

This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

P-One Clinic

Hachiōji, Tokyo, 192-0071, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult healthy subjects
  • Body mass index: >=18.5 and <25.0

Exclusion criteria

  • Subject with any disease or any history of disease that might be unsuitable for participation in the clinical study

Treatment and study plan

FYU-981

Drug

Single administration

Oxaprozin

Drug

Repeated administration

Primary outcomes

  1. Pharmacokinetics (Cmax: Maximum plasma concentration)

    Time frame: 48 hours

  2. Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)

    Time frame: 48 hours

  3. Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)

    Time frame: 48 hours

  4. Pharmacokinetics (AUC: Area under the plasma concentration-time curve)

    Time frame: 48 hours

  5. Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)

    Time frame: 48 hours

  6. Pharmacokinetics (kel: Elimination rate constant)

    Time frame: 48 hours

  7. Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)

    Time frame: 48 hours

  8. Pharmacokinetics (MRT: Mean residence time)

    Time frame: 48 hours

  9. Safety (Incidence of treatment-emergent adverse event)

    Time frame: 20 days

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Collaborators

  • Fuji Yakuhin Co., Ltd.

Registry information

Official study title

Drug-drug Interaction Study to Evaluate the Pharmacokinetics and Safety of FYU-981 and Oxaprozin in Healthy Male Adults Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2017
Registry last updated
Sep 14, 2022

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.