Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy Subjects at Fed State

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DA-5210 10/500mg; Drug: DA-5210-R 10/500mg

• Registration Number: NCT05098275
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

Phamacokinetics and safety profiles of DA-5210 10/500mg in Healthy subjects at Fed State

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study Start: 2021-10-26
• Study First Posted: 2021-10-28
• Primary Completion: 2022-02-06
• Study Completion: 2022-02-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	DA-5210 10/500mg	-
Sequence A	DA-5210-R 10/500mg	-
Sequence B	DA-5210 10/500mg	-
Sequence B	DA-5210-R 10/500mg	-

Primary Outcome Measures

Name	Time	Method
AUCt	pre-dose~48 hours post-dose	area under the curve
Cmax	pre-dose~48 hours post-dose	maximum plasma concentration

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of