Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315

Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Period 1; Drug: Period 2; Drug: Period 3; Drug: Period 4

Detailed Description

The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: SHIN, CPL; Phone Number: 02-550-8858

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A: RTRT; T: DWJ1589 R: DWC202315	Drug: Period 1; DWJ1589 or DWC202315; Drug: Period 2; DWJ1589 or DWC202315; Drug: Period 3; DWJ1589 or DWC202315; Drug: Period 4; DWJ1589 or DWC202315
Experimental: Sequence B: TRTR; T: DWJ1589 R: DWC202315	Drug: Period 1; DWJ1589 or DWC202315; Drug: Period 2; DWJ1589 or DWC202315; Drug: Period 3; DWJ1589 or DWC202315; Drug: Period 4; DWJ1589 or DWC202315

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315	Cmax of DWJ1589 and DWC202315	At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
The Area under the curve(AUC)last of DWJ1589 and DWC202315	AUClast of DWJ1589 and DWC202315	At pre-dose (0 hour), and post-dose 0.83 to 72 hour.

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: KANG, MD, PhD, H Plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1589101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No