Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy Subjects at Fasting State
Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05098262
Collaborator
(none)
40
1
2
2.1
19
Study Details
Study Description
Brief Summary
Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy subjects at Fasting State
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/500mg in Healthy Subjects at Fasting State
Actual Study Start Date
:
Oct 31, 2021
Actual Primary Completion Date
:
Jan 3, 2022
Actual Study Completion Date
:
Jan 3, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence A
|
Drug: DA-5210 10/500mg
single dose administration (one tablet once a day)
Drug: DA-5210-R 10/500mg
single dose administration (one tablet once a day)
|
| Experimental: Sequence B
|
Drug: DA-5210 10/500mg
single dose administration (one tablet once a day)
Drug: DA-5210-R 10/500mg
single dose administration (one tablet once a day)
|
Outcome Measures
Primary Outcome Measures
- AUCt [pre-dose~48 hours post-dose]
area under the curve
- Cmax [pre-dose~48 hours post-dose]
maximum plasma concentration
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | H Plus Yangji Hospital | Seoul | Korea, Republic of | 08779 |
Sponsors and Collaborators
- Dong-A ST Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05098262
Other Study ID Numbers:
- BIBE2021-51
First Posted:
Oct 28, 2021
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No