NCT05465668

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2022

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

First Submitted

Initial submission to the registry

July 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 22, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

January 31, 2023

Status Verified

July 1, 2022

Enrollment Period

25 days

First QC Date

July 5, 2022

Last Update Submit

January 30, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss of DWP16001

    Peak Plasma Concetration of DWP16001

    At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

  • AUClast of DWP16001

    The area under the plasma drug concentration-time curve of DWP16001

    At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

Secondary Outcomes (4)

  • Tmax of DWP16001

    At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

  • T1/2 of DWP16001

    At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

  • CL/F of DWP16001

    At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

  • Vd/F of DWP16001

    At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

Study Arms (2)

Intervention: DWP16001 Drug A

EXPERIMENTAL

1 tablet, Oral, once daily single dose

Drug: DWP16001 Drug A

Intervention: DWP16001 Drug C

EXPERIMENTAL

1 tablet, Oral, once daily single dose

Drug: DWP16001 Drug C

Interventions

DWP16001 Drug ADRUG

DWP16001 Drug A

Intervention: DWP16001 Drug A
DWP16001 Drug CDRUG

DWP16001 Drug C

Intervention: DWP16001 Drug C

Eligibility Criteria

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

You may qualify if:

  • \- 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

You may not qualify if:

  • musculoskeletal diseases
  • mental diseases
  • hemato-oncologic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA unuversity bundang medical center

Seongnam, 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

July 5, 2022

First Posted

July 20, 2022

Study Start

July 22, 2022

Primary Completion

August 16, 2022

Study Completion

November 22, 2022

Last Updated

January 31, 2023

Record last verified: 2022-07

Locations

KR(1)