Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05465668

Enrollment

Registered

2022-07-20

Start date

2022-07-22

Completion date

2022-11-22

Last updated

2023-01-31

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 DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.

Detailed 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 DWP16001.

Interventions

DRUGDWP16001 Drug A

DWP16001 Drug A

DRUGDWP16001 Drug C

DWP16001 Drug C

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

\- Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2 ☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2

Exclusion criteria

* musculoskeletal diseases * mental diseases * hemato-oncologic diseases

Design outcomes

Primary

Measure	Time frame	Description
Cmax,ss of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.	Peak Plasma Concetration of DWP16001
AUClast of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.	The area under the plasma drug concentration-time curve of DWP16001

Secondary

Measure	Time frame	Description
Tmax of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.	Time at Cmax of DWP16001
T1/2 of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.	Half life of DWP16001
CL/F of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.	Apparent total clearance of the drug from plasma after oral administration of DWP16001
Vd/F of DWP16001	At pre-dose (0 hour), and post-dose 0.25 to 72 hour.	Volume of distribution of DWP16001

Countries

South Korea

Outcome results

None listed

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