Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DWJ1622, DWC202313, DWC202314.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "DWJ1622" and Co-administration of "DWC202313" and "DWC202314" in Healthy Volunteers
Overview
This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fed conditions.
Detailed description
This is an open-label, randomized, oral, single-dose, 2-sequence, 2-period, crossover Phase 1 study to evaluate the pharmacokinetics and safety profiles of DWJ1622, DWC202313, and DWC202314 in healthy volunteers under fed conditions. Subjects will be randomized to receive either DWJ1622 or the co-administration of DWC202313 and DWC202314 in different sequences across two study periods with an appropriate washout period.
The primary pharmacokinetic endpoints include the maximum observed plasma concentration (Cmax) and the area under the plasma concentration-time curve to the last measurable concentration (AUClast) of each study drug. Secondary endpoints include the area under the plasma concentration-time curve extrapolated to infinity (AUCinf), the ratio of AUClast to AUCinf (AUClast/AUCinf), the time to reach maximum plasma concentration (Tmax), and the terminal elimination half-life (t1/2). Safety will be evaluated based on adverse events and clinical laboratory tests.
Interventions
- Drug DWJ1622
DWJ1622 (single oral dose) is administered in accordance with the study protocol. - Drug DWC202313, DWC202314
DWC202313, DWC202314(single oral dose) is administered in accordance with the study protocol.
Primary outcome measures
- Cmax [Time frame: At pre-dose (0 hours), and post-dose 1 to 72 hours.]
- AUClast [Time frame: Time Frame: At pre-dose (0 hours), and post-dose 1 to 72 hours.]
Secondary outcome measures (3)
- AUCinf [Time frame: At pre-dose (0 hours), and post-dose 1 to 72 hours.]
- AUClast/AUCinf [Time frame: At pre-dose (0 hours), and post-dose 1 to 72 hours.]
- Tmax [Time frame: At pre-dose (0 hours), and post-dose 1 to 72 hours.]
Eligibility criteria
Inclusion criteria
- Over 19 year old
- Healthy adult volunteers
Exclusion criteria
- with a history of mental disorder
- For female volunteers, those who are suspected of being pregnant or lactating
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- H Plus YANGJI Hospital — Seoul
Identifiers
NCT: NCT07267221 · DW_DWJ1622103