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NCT05449704 Clinical Trial

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

Healthy Clinical Trial

Official title:
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05449704
Other study ID # DA5218_BE_I
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date July 8, 2022
Est. completion date September 7, 2022

Study information
Verified date July 2022
Source Dong-A ST Co., Ltd.
Contact JiHyun Sung
Phone +82-2-920-8369
Email jhsung@donga.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 90
Est. completion date September 7, 2022
Est. primary completion date September 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DA-5218
single dose administration (DA-5218 one tablet once a day)
• DA-5218-R1 + DA-5218-R2 + DA-5218-R3
single dose administration (DA-5218-R1 one tablet once a day + DA-5218-R2 one tablet once a day + DA-5218-R3 one tablet once a day)

Locations
Country Name City State
Korea, Republic of Bumin Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt area under the curve pre-dose~72 hours post-dose
Primary Cmax maximum plasma concentration pre-dose~72 hours post-dose
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