Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)

Fuji Yakuhin Co., Ltd.18 enrolled

Overview

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Renal Insufficiency Healthy

Interventions

FYU-981, (Oral single dosing)DRUG

FYU-981, (Oral single dosing)

Eligibility

Sex: MALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese adult subjects * Body mass index: \>=18.5 and \<30.0 Exclusion Criteria: * Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Locations (1)

Japan

Kagoshima, Japan

Outcomes

Primary Outcomes

Pharmacokinetics (Cmax: Maximum plasma concentration)

Time frame: 48 hours

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

Time frame: 48 hours

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

Time frame: 48 hours

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

Time frame: 48 hours

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

Time frame: 48 hours

Pharmacokinetics (kel: Elimination rate constant)

Time frame: 48 hours

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

Time frame: 48 hours

Pharmacokinetics (MRT: Mean residence time)

Time frame: 48 hours

Pharmacokinetics (Ae: Amount of drug excreted in urine)

Time frame: 48 hours

Pharmacokinetics (fe: Fraction of dose excreted in urine)

Time frame: 48 hours

Data from ClinicalTrials.gov

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