Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

Phase 1

• Conditions: Healthy
• Interventions: Drug: DA-5218; Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3

• Registration Number: NCT05449704
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

Pharmacokinetics and safety Profiles after administration of DA-5218 and co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in healthy adult volunteers

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Last Update Submitted: 2022-07-04
• Study Start: 2022-07-08
• Study First Posted: 2022-07-08
• Last Update Posted: 2022-07-08
• Primary Completion: 2022-09-03
• Study Completion: 2022-09-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Healthy volunteers
• BMI between 18 and 30 kg/m2
• Body weight: Male≥50kg, Female≥45kg
• Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria

• Subjects with allergy or drug hypersensitivity
• Subjects with clinically significant medical history
• Subjects with history of drug abuse or addicted

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	DA-5218	-
Sequence A	DA-5218	-
Sequence A	DA-5218-R1 + DA-5218-R2 + DA-5218-R3	-
Sequence B	DA-5218-R1 + DA-5218-R2 + DA-5218-R3	-

Primary Outcome Measures

Name	Time	Method
AUCt	pre-dose~72 hours post-dose	area under the curve
Cmax	pre-dose~72 hours post-dose	maximum plasma concentration

Trial Locations

Locations (1)

Bumin Hospital; 🇰🇷 Seoul, Korea, Republic of