Pharmacokinetics and Safety Following Administration of DWP16001

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05414591

Enrollment

Registered

2022-06-10

Start date

2021-05-01

Completion date

2021-08-01

Last updated

2022-07-13

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

Conditions

Healthy

Brief summary

To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers

Interventions

DRUGDWP16001 drug A

1 tablet, Oral, once daily single dose

DRUGDWP16001 drug B

3 tablet, Oral, once daily single dose

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

* Healthy adult volunteers aged ≥ 19 years at screening * 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 * Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination * Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.

Exclusion criteria

* Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder * Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug * Clinical laboratory test values are outside the accepted normal range at screening * Other exclusive inclusion criteria, as defined in the protocol

Design outcomes

Primary

Measure	Time frame	Description
Cmax of DWP16001	0-72 hours	Peak Plasma Concetration
AUC0_t of DWP16001	0-72 hours	Area under the plasma concentration versus time curve

Secondary

Measure	Time frame	Description
T 1/2 of DWP16001	0-72 hours	half life of DWP16001
Tmax Tmax	0-72 hours	Time at Cmax Tmax
Vd/F of DWP16001	0-72 hours	Volume of distribution
CL/F of DWP16001	0-72 hours	Apparent total clearance of the drug from plasma after oral administration
AUC of DWP16001	0-72 hours	Area under the plasma concentration versus time curve

Countries

South Korea

Outcome results

None listed

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