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NCT05954247 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05954247
Other study ID # DW_DWJ1543101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2023
Est. completion date December 1, 2023

Study information
Verified date July 2023
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 24
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWJ1543
DWJ1543
• DWC202216
DWC202216

Locations
Country Name City State
n/a

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

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543 At pre-dose (0 hour), and post-dose 1 to 120 hour.
Primary 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.
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