To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

JW Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical); Drug: Epaminurad 9 mg (JW Pharmaceutical)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07374406

JW25103

Details and patient eligibility

About

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

Enrollment: 34 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group 1

Experimental group

Description:

Subjects receive a single dose of Treatment A (JW Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 2.

Treatment:

Drug: Epaminurad 9 mg (JW Pharmaceutical)

Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical)

Group 2

Experimental group

Description:

Subjects receive a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment A (JW Pharmaceutical) in Period 2.

Treatment:

Drug: Epaminurad 9 mg (JW Pharmaceutical)

Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical)