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Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315

Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06592495
Enrollment
52
Registered
2024-09-19
Start date
2024-10-31
Completion date
2025-10-31
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

Detailed description

The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

Interventions

DRUGPeriod 1

DWJ1589 or DWC202315

DRUGPeriod 2

DWJ1589 or DWC202315

DRUGPeriod 3

DWJ1589 or DWC202315

DRUGPeriod 4

DWJ1589 or DWC202315

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315At pre-dose (0 hour), and post-dose 0.83 to 72 hour.Cmax of DWJ1589 and DWC202315
The Area under the curve(AUC)last of DWJ1589 and DWC202315At pre-dose (0 hour), and post-dose 0.83 to 72 hour.AUClast of DWJ1589 and DWC202315

Contacts

Primary ContactSHIN, CPL
02-550-8858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026