Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DWC202313, DWC202314; Drug: DWJ1622

Study type: Interventional

Funder types: Industry

Identifiers

NCT07260851

DW_DWJ1622102

Details and patient eligibility

About

This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fasting conditions.

Full description

This is an open-label, randomized, oral, single-dose, 2-sequence, 2-period, crossover Phase 1 study designed to compare the pharmacokinetics and safety profiles of DWJ1622 with the co-administration of DWC202313 and DWC202314 in healthy volunteers under fasting conditions. Subjects will be randomized to receive either DWJ1622 or the co-administration of DWC202313 and DWC202314 in different sequences across two study periods with an appropriate washout period.

The primary pharmacokinetic endpoints include the maximum observed plasma concentration (Cmax) and the area under the plasma concentration-time curve to the last measurable concentration (AUClast) of each study drug. Secondary endpoints include the area under the plasma concentration-time curve extrapolated to infinity (AUCinf), the ratio of AUClast to AUCinf (AUClast/AUCinf), the time to reach maximum plasma concentration (Tmax), and the terminal elimination half-life (t1/2). Safety will be evaluated based on adverse events and clinical laboratory tests.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 19 year old
• Healthy adult volunteers

Exclusion criteria

• with a history of mental disorder
• For female volunteers, those who are suspected of being pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

DWJ1622

Experimental group

Treatment:

Drug: DWJ1622

Drug: DWC202313, DWC202314

DWC202313, DWC202314

Experimental group

Treatment:

Drug: DWJ1622

Drug: DWC202313, DWC202314