NCT05414591

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
Last Updated

July 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 8, 2022

Last Update Submit

July 11, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUC0_t of DWP16001

    Area under the plasma concentration versus time curve

    0-72 hours

  • Cmax of DWP16001

    Peak Plasma Concetration

    0-72 hours

Secondary Outcomes (5)

  • Tmax Tmax

    0-72 hours

  • AUC of DWP16001

    0-72 hours

  • T 1/2 of DWP16001

    0-72 hours

  • CL/F of DWP16001

    0-72 hours

  • Vd/F of DWP16001

    0-72 hours

Study Arms (2)

Sequence group A

EXPERIMENTAL

DWP16001 A mg 1T

Drug: DWP16001 drug ADrug: DWP16001 drug B

Sequence group B

EXPERIMENTAL

DWP16001 B mg 3T

Drug: DWP16001 drug ADrug: DWP16001 drug B

Interventions

DWP16001 drug ADRUG

1 tablet, Oral, once daily single dose

Sequence group ASequence group B
DWP16001 drug BDRUG

3 tablet, Oral, once daily single dose

Sequence group ASequence group B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 10, 2022

Study Start

May 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

July 13, 2022

Record last verified: 2022-06

Locations

KR(1)