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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06010589
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.5
• Patients Per Site Per Month: 14.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: DWJ1558; Drug: DWC202310 and DWC202311	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bioequivalence Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1558 and Co-administration of DWC202310 and DWC202311 in Healthy Volunteers
• Actual Study Start Date: Aug 17, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention: DWJ1558	Drug: DWJ1558; DWJ1558
Experimental: Intervention: DWC202310 and DWC202311	Drug: DWC202310 and DWC202311; Co-administration of DWC202310 and DWC202311

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• over 19 year old

Exclusion Criteria:

• Pancreatitis

• Diabetic ketoacidosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Plus YANGJI Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT06010589
• Other Study ID Numbers: DWJ1558101
• First Posted: Aug 24, 2023
• Last Update Posted: Aug 30, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 30, 2023