Drug-drug Interaction Study of FYU-981 and Oxaprozin

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350386
• Other study ID #: FYU-981-017
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2017
• Est. completion date: December 5, 2017

Study information

• Verified date: September 2022
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 5, 2017
• Est. primary completion date: December 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• FYU-981
Single administration
• Oxaprozin
Repeated administration

Locations

Country	Name	City	State
Japan	P-One Clinic	Hachioji	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.	Fuji Yakuhin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (Cmax: Maximum plasma concentration)		48 hours
Primary	Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)		48 hours
Primary	Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)		48 hours
Primary	Pharmacokinetics (AUC: Area under the plasma concentration-time curve)		48 hours
Primary	Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)		48 hours
Primary	Pharmacokinetics (kel: Elimination rate constant)		48 hours
Primary	Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)		48 hours
Primary	Pharmacokinetics (MRT: Mean residence time)		48 hours
Primary	Safety (Incidence of treatment-emergent adverse event)		20 days