Pharmacokinetics and Safety Profiles After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteers
Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05132049
Collaborator
(none)
42
1
2
2.2
19.4
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteer
Actual Study Start Date
:
Dec 18, 2021
Actual Primary Completion Date
:
Feb 22, 2022
Actual Study Completion Date
:
Feb 22, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence A
|
Drug: DA-5211
single dose administration (DA-5211 one tablet once a day)
Drug: DA-5211-R1 + DA-5211-R2
single dose administration (DA-5211-R1 one tablet once a day + DA-5211-R2 one tablet once a day)
|
| Experimental: Sequence B
|
Drug: DA-5211
single dose administration (DA-5211 one tablet once a day)
Drug: DA-5211-R1 + DA-5211-R2
single dose administration (DA-5211-R1 one tablet once a day + DA-5211-R2 one tablet once a day)
|
Outcome Measures
Primary Outcome Measures
- AUCt [pre-dose~72 hours post-dose]
area under the curve
- Cmax [pre-dose~72 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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bumin Hospital | Seoul | Korea, Republic of | 07590 |
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:
NCT05132049
Other Study ID Numbers:
- DA5211_BE_I
First Posted:
Nov 23, 2021
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No