To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

Phase 1RecruitingNCT07374406

JW Pharmaceutical34 enrolled

Overview

A randomized, open-label, single dose, 2x2 crossover study to evaluate the safety and pharmacokinetic characteristics after administration of Epaminurad in healthy adult volunteers under fasting conditions

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Epaminurad 9 mg (JW Pharmaceutical)DRUG

Test product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.

Epaminurad 9 mg (Shanghai STA Pharmaceutical)DRUG

Reference product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 19\~55 2. Weight: at least 50 kg for males and 45 kg for females. Body Mass Index(BMI): 18.0 kg/m\^2 or heavier and below 30.0 kg/m\^2 Exclusion Criteria: 1. Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality 2. Clinical examination- eGFR (CKD-EPI) \< 60mL/min/1.73m\^2, AST (SGOT), ALT (SGPT) \> upper limit of normal ranges X 2, CK \> upper limit of normal ranges X 5, Positive serologic results Cystatin C \> 1.26mg/L

Locations (1)

Jeonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC)

To evaluate the AUC of Epaminurad

Time frame: 3 days

Peak plasma concentrations (Cmax)

To evaluate the Cmax of Epaminurad

Time frame: 3 days

Central Contacts

JW Pharmaceutical

CONTACT

+82-2-840-6862 jinha.jeong@jwhealthcare.com

Data from ClinicalTrials.gov

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