Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects

Phase 1

Recruiting

• Conditions: Drug Drug Interaction
• Interventions: Drug: DWC202313; Drug: DWC202314

• Registration Number: NCT06119958
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study Start: 2023-10-27
• Study First Submitted QC: 2023-11-05
• Last Update Submitted: 2023-11-05
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• over 19 year old

Exclusion Criteria

• Galactose intolerance
• Lapp lactase deficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWC202313	DWC202313	DWC202313
DWC202314	DWC202314	DWC202314

Primary Outcome Measures

Name	Time	Method
Cmax,ss of DWC202313 and DWC202314	Up to 14 days
AUCt,ss of DWC202313 and DWC202314	Up to 14 days

Secondary Outcome Measures

Name	Time	Method
Vdss/F of DWC202313 and DWC202314	Up to 14 days
PTF of DWC202313 and DWC202314	Up to 14 days
Tmax,ss of DWC202313 and DWC202314	Up to 14 days
Cmin,ss of DWC202313 and DWC202314	Up to 14 days
t1/2 of DWC202313 and DWC202314	Up to 14 days
CLss/F of DWC202313 and DWC202314	Up to 14 days

Trial Locations

Locations (1)

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