Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: DWC202310 and DWC202311; Drug: DWJ1558

• Registration Number: NCT06010589
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-17
• Study First Submitted: 2023-08-20
• Study First Submitted QC: 2023-08-20
• Study First Posted: 2023-08-24
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• over 19 year old

Exclusion Criteria

• Pancreatitis
• Diabetic ketoacidosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention: DWC202310 and DWC202311	DWC202310 and DWC202311	-
Intervention: DWJ1558	DWJ1558	-

Primary Outcome Measures

Name	Time	Method
Cmax,ss of DWJ1558	At pre-dose (0 hour), and post-dose 1 to 72 hour.	Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1558
AUCt of DWJ1558	At pre-dose (0 hour), and post-dose 1 to 72 hour.	Area under the curve from the time of dosing to the last measurable concentration(AUCt) of DWJ1558

Trial Locations

Locations (1)

H Plus YANGJI Hospital; 🇰🇷 Seoul, Korea, Republic of