Drug-drug Interaction Study of FYU-981 and Oxaprozin

Mochida Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oxaprozin; Drug: FYU-981

Study type: Interventional

Funder types: Industry

Identifiers

NCT03350386

FYU-981-017

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Single dose

Experimental group

Description:

Single administration of FYU-981

Treatment:

Drug: FYU-981

Concomitant administration

Experimental group

Description:

Concomitant administration of FYU-981 with oxaprozin at steady state

Treatment:

Drug: Oxaprozin

Drug: FYU-981