Pharmacokinetics and Safety Profiles After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DA-5211; Drug: DA-5211-R1 + DA-5211-R2

• Registration Number: NCT05132049
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

Pharmacokinetics and safety Profiles after administration of DA-5211 and co-administration of DA-5211-R1 and DA-5211-R2 in healthy adult volunteers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-23
• Study Start: 2021-12-18
• Primary Completion: 2022-02-22
• Study Completion: 2022-02-22
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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-5211-R1 + DA-5211-R2	-
Sequence A	DA-5211	-
Sequence A	DA-5211-R1 + DA-5211-R2	-
Sequence B	DA-5211	-

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