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Drug-drug Interaction Study of FYU-981 and Oxaprozin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03350386
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : December 12, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: FYU-981 Drug: Oxaprozin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Drug-drug Interaction Study to Evaluate the Pharmacokinetics and Safety of FYU-981 and Oxaprozin in Healthy Male Adults Subjects
Actual Study Start Date : November 2, 2017
Primary Completion Date : December 5, 2017
Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single dose
Single administration of FYU-981
Drug: FYU-981
Single administration
Experimental: Concomitant administration
Concomitant administration of FYU-981 with oxaprozin at steady state
Drug: FYU-981
Single administration
Drug: Oxaprozin
Repeated administration

Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: 48 hours ]
    T1/2: Elimination half-life of plasma concentration

  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350386

P-One Clinic
Hachiōji, Tokyo, Japan, 192-0071
Sponsors and Collaborators
Mochida Pharmaceutical Company, Ltd.
Fuji Yakuhin Co., Ltd.
Study Director: Nagasawa Katsuaki Clinical Research Department
More Information

Responsible Party: Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier: NCT03350386     History of Changes
Other Study ID Numbers: FYU-981-017
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents