PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers

Phase 1CompletedNCT06665425

JW Pharmaceutical18 enrolled

Overview

A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Epaminurad 9 mgDRUG

Period 1: Epaminurad / Period 2: C2406 -\> Epaminurad + C2406

C2406DRUG

Period 1: Epaminurad / Period 2: C2406 -\> Epaminurad + C2406

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 19\~50 2. Weight: between 50.0 kg\~90.0 kg, 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) \< 90mL/min/1.73m\^2 * Serum uric acid \< 3 mg/dL or \> 7 mg/dL * AST (SGOT), ALT (SGPT) \> upper limit of normal ranges X 1.5 * Total bilirubin, γ-GTP \> upper limit of normal ranges X 1.5 * CK \> upper limit of normal ranges X 2 * Positive serologic results

Locations (1)

Seoul National University Hospital Clinical Trials Center

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC)

To evaluate the AUC of Epaminurad and C2406

Time frame: 7 days

Peak plasma concentrations (Cmax)

To evaluate the Cmax of Epaminurad and C2406

Time frame: 7 days

Data from ClinicalTrials.gov

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