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NCT05739877 Clinical Trial

Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fed State

Healthy Clinical Trial

Official title:
An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 2.5/500mg in Healthy Subjects at Fed State

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05739877
Other study ID # 22-4248-BE023
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date March 17, 2023
Est. completion date April 7, 2023

Study information
Verified date February 2023
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 34
Est. completion date April 7, 2023
Est. primary completion date April 7, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Healthy Volunteers - BMI between 18 and 30 kg/m2 - Body weight : Male=50kg, Female=45kg Exclusion Criteria: - Allergy or Drug hypersensitivity - Clinically significant Medical History

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DA-1229_01 2.5/500mg (Before)
single dose administration (one tablet once a day)
• DA-1229_01 2.5/500mg (After)
single dose administration (one tablet once a day)

Locations
Country Name City State
Korea, Republic of Metro Hospital Anyang-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt area under the curve pre-dose~48 hours post-dose
Primary Cmax maximum plasma concentration pre-dose~48 hours post-dose
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