PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
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: DWJ1511, DWC202501.
- Who it may be relevant to
- Registry conditions: Healthy Subjects. Basic parameters: 19 years — 64 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, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of "DWJ1511" and "DWC202501" in Healthy Adult Volunteers
Overview
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
Detailed description
This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.
Interventions
- Drug DWJ1511
Test drug: DWJ1511 - Drug DWC202501
Comparator: DWC202501
Primary outcome measures
- Area under the plasma drug concentration-time curve [AUCt] [Time frame: 0-12 Hours]
- Maximum plasma concentration [Cmax] [Time frame: 0-12 Hours]
Secondary outcome measures (1)
- Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] [Time frame: 0-12 Hours]
Eligibility criteria
Inclusion criteria
- Male or female participants aged ≥19 years and <65 years at the time of screening
- Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height \[m\]²)
Exclusion criteria
- Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
- Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.
- Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).
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: NCT07144176 · DW_DWJ1511101