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NCT06119958 Clinical Trial

Drug-drug Interactions Between DWC202313 and DWC202314 in Healthy Subjects

Drug Drug Interaction Clinical Trial

Official title:
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06119958
Other study ID # DWJ1622101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 27, 2023
Est. completion date December 2023

Study information
Verified date October 2023
Source Daewoong Pharmaceutical Co. LTD.
Contact Seung-Hyun Kang, MD, Ph D
Phone 070-4665-9490
Email juspa@newyjh.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 32
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria: - over 19 year old Exclusion Criteria: - Galactose intolerance - Lapp lactase deficiency

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWC202313
Experimental Drug 1
• DWC202314
Experimental Drug 2

Locations
Country Name City State
Korea, Republic of H Plus YANGJI Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax,ss of DWC202313 and DWC202314 Up to 14 days
Primary AUCt,ss of DWC202313 and DWC202314 Up to 14 days
Secondary Tmax,ss of DWC202313 and DWC202314 Up to 14 days
Secondary Cmin,ss of DWC202313 and DWC202314 Up to 14 days
Secondary t1/2 of DWC202313 and DWC202314 Up to 14 days
Secondary CLss/F of DWC202313 and DWC202314 Up to 14 days
Secondary Vdss/F of DWC202313 and DWC202314 Up to 14 days
Secondary PTF of DWC202313 and DWC202314 Up to 14 days
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