Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers

Bioequivalence Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1558 and Co-administration of DWC202310 and DWC202311 in Healthy Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06010589

Enrollment

Registered

2023-08-24

Start date

2023-08-17

Completion date

2024-01-31

Last updated

2023-08-30

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 compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.

Interventions

DRUGDWJ1558

DWJ1558

DRUGDWC202310 and DWC202311

Co-administration of DWC202310 and DWC202311

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

Exclusion criteria

* Pancreatitis * Diabetic ketoacidosis

Design outcomes

Primary

Measure	Time frame	Description
Cmax,ss of DWJ1558	At pre-dose (0 hour), and post-dose 1 to 72 hour.	Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1558
AUCt of DWJ1558	At pre-dose (0 hour), and post-dose 1 to 72 hour.	Area under the curve from the time of dosing to the last measurable concentration(AUCt) of DWJ1558

Countries

South Korea

Outcome results

None listed

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