Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DA-5213 10mg; Drug: DA-5213-R 10mg

• Registration Number: NCT05106205
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-24
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-03
• Study Start: 2021-12-21
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy Volunteers
• BMI between 18.0 and 30.0 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-5213 10mg	-
Sequence A	DA-5213-R 10mg	-
Sequence B	DA-5213 10mg	-
Sequence B	DA-5213-R 10mg	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Central Hospital; 🇰🇷 Siheung-si, Gyeonggi-do, Korea, Republic of