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Clinical Pharmacology of FYU-981 (Final Formulation)

NCT03350373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-12-12

No results posted yet for this study

Summary

This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.

Conditions

  • Healthy

Interventions

DRUG

FYU-981

Single administration of FYU-981 under Fasted and fed conditions in the morning.

Sponsors & Collaborators

  • Fuji Yakuhin Co., Ltd.

    collaborator INDUSTRY

  • Mochida Pharmaceutical Company, Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuaki Nagasawa · Clinical Research Department

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2017-11-29
Completion
2017-11-29

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350373 on ClinicalTrials.gov