NCT05739877

Brief Summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01(2.5/500 mg x1 tablets) at fed state

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

February 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

March 17, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

21 days

First QC Date

February 13, 2023

Last Update Submit

February 13, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

    area under the curve

    pre-dose~48 hours post-dose

  • Cmax

    maximum plasma concentration

    pre-dose~48 hours post-dose

Study Arms (2)

Sequence A(Before→ After)

EXPERIMENTAL
Drug: DA-1229_01 2.5/500mg (Before)Drug: DA-1229_01 2.5/500mg (After)

Sequence B(After→ Before)

EXPERIMENTAL
Drug: DA-1229_01 2.5/500mg (Before)Drug: DA-1229_01 2.5/500mg (After)

Interventions

DA-1229_01 2.5/500mg (Before)DRUG

single dose administration (one tablet once a day)

Sequence A(Before→ After)Sequence B(After→ Before)
DA-1229_01 2.5/500mg (After)DRUG

single dose administration (one tablet once a day)

Sequence A(Before→ After)Sequence B(After→ Before)

Eligibility Criteria

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

You may qualify if:

  • Healthy Volunteers
  • BMI between 18 and 30 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)

Metro Hospital

Anyang-si, Gyeonggi-do, 14096, South Korea

Location

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

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

February 13, 2023

First Posted

February 22, 2023

Study Start

March 17, 2023

Primary Completion

April 7, 2023

Study Completion

April 7, 2023

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

KR(1)