Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05954247
• Collaborator: (none)
• Enrollment: 24
• Arms: 2
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief Summary

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: DWJ1543; Drug: DWC202216	Phase 1

Detailed Description

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers Under Fasting Conditions
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention: DWJ1543	Drug: DWJ1543; DWJ1543
Experimental: Intervention: DWC202216	Drug: DWC202216; DWC202216

Outcome Measures

Primary Outcome Measures

1. Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543 [At pre-dose (0 hour), and post-dose 1 to 120 hour.]

2. Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543 [At pre-dose (0 hour), and post-dose 1 to 120 hour.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Over 19 year old

• Healthy adult volunteers

Exclusion Criteria:

• Eye disorders including cataracts

• Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders

Contacts and Locations

Locations

No locations specified.

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: NCT05954247
• Other Study ID Numbers: DW_DWJ1543101
• First Posted: Jul 20, 2023
• Last Update Posted: Jul 24, 2023
• Last Verified: Jul 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 Jul 24, 2023