Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: DA-1229_01 5/1000mg (Before); Drug: DA-1229_01 5/1000mg (After)

• Registration Number: NCT05739903
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 (5/1000 mg x1 tablets) at fasting state.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Study Start: 2023-03-25
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21

Recruitment & Eligibility

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

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 B(After→ Before)	DA-1229_01 5/1000mg (After)	-
Sequence A(Before→ After)	DA-1229_01 5/1000mg (After)	-
Sequence A(Before→ After)	DA-1229_01 5/1000mg (Before)	-
Sequence B(After→ Before)	DA-1229_01 5/1000mg (Before)	-

Primary Outcome Measures

Name	Time	Method
AUCt	pre-dose~96 hours post-dose	area under the curve
Cmax	pre-dose~96 hours post-dose	maximum plasma concentration

Trial Locations

Locations (1)

Metro Hospital; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of