Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult Volunteers

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06119945
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Anticipated Duration (Days): 22
• Patients Per Site Per Month: 60.9

Study Details

Study Description

Brief Summary

This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: DWJ1568; Drug: DWC202215	Phase 1

Detailed Description

The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1568 and DWC202215. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1568 and DWC202215.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers
• Anticipated Study Start Date: Nov 9, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DWJ1568 DWJ1568	Drug: DWJ1568; One tablet of DWJ1568
Active Comparator: DWC202215 DWC202215	Drug: DWC202215; One tablet of DWC202215

Outcome Measures

Primary Outcome Measures

1. Cmax,ss of DWJ1568 and DWC202215 [At pre-dose (0 hour), and post-dose 0 to 72 hour.]

2. AUCt of DWJ1568 and DWC202215 [At pre-dose (0 hour), and post-dose 0 to 72 hour.]

Secondary Outcome Measures

1. AUCinf of DWJ1568 and DWC202215 [At pre-dose (0 hour), and post-dose 0 to 72 hour.]

2. Tmax of DWJ1568 and DWC202215 [At pre-dose (0 hour), and post-dose 0 to 72 hour.]

3. AUCt/AUCinf of DWJ1568 and DWC202215 [At pre-dose (0 hour), and post-dose 0 to 72 hour.]

4. t1/2 of DWJ1568 and DWC202215 [At pre-dose (0 hour), and post-dose 0 to 72 hour.]

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:

• Galactose intolerance

• Lapp lactase deficiency

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: NCT06119945
• Other Study ID Numbers: DWJ1568101
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Oct 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 Nov 7, 2023