NCT05106205

Brief Summary

Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_1 healthy

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

October 24, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

October 24, 2021

Last Update Submit

June 10, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

    area under the curve

    [Time Frame: pre-dose~48 hours post-dose]

  • Cmax

    maximum plasma concentration

    [Time Frame: pre-dose~48 hours post-dose]

Study Arms (2)

Sequence A

EXPERIMENTAL
Drug: DA-5213 10mgDrug: DA-5213-R 10mg

Sequence B

EXPERIMENTAL
Drug: DA-5213 10mgDrug: DA-5213-R 10mg

Interventions

DA-5213 10mgDRUG

single dose administration (one tablet once a day)

Sequence ASequence B
DA-5213-R 10mgDRUG

single dose administration (one tablet once a day)

Sequence ASequence B

Eligibility Criteria

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

You may qualify if:

  • Healthy Volunteers
  • BMI between 18.0 and 30.0 kg/m2
  • Body weight : Male≥50kg, Female≥45kg

You may not qualify if:

  • Allergy or Drug hypersensitivity
  • Clinically significant Medical History

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital

Siheung-si, Gyeonggi-do, 15079, 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

October 24, 2021

First Posted

November 3, 2021

Study Start

December 21, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06

Locations

KR(1)