PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Phase 1RecruitingNCT07144176

Daewoong Pharmaceutical Co. LTD.60 enrolled

Overview

This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

DWJ1511DRUG

Test drug: DWJ1511

DWC202501DRUG

Comparator: DWC202501

Eligibility

Sex: ALLMin age: 19 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female participants aged ≥19 years and \<65 years at the time of screening * Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height \[m\]²) Exclusion Criteria: * Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration. * Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration. * Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).

Locations (1)

H Plus Yangji Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Area under the plasma drug concentration-time curve [AUCt]

Area under the plasma drug concentration-time curve \[AUCt\] of DWJ1511 and DWC202501

Time frame: 0-12 Hours

Maximum plasma concentration [Cmax]

Maximum plasma concentration \[Cmax\] of DWJ1511 and DWC202501

Time frame: 0-12 Hours

Secondary Outcomes

Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]

Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCinf\] of DWJ1511 and DWC202501

Time frame: 0-12 Hours

Central Contacts

Kang

CONTACT

82) 070-4665-9490 juspa@newyjh.com

Data from ClinicalTrials.gov

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