Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)
Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04938752
Collaborator
(none)
30
1
2
1.4
21.2
Study Details
Study Description
Brief Summary
This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 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, Safety and Tolerability of DA 2811 in Healthy Subjects
Actual Study Start Date
:
Jul 8, 2021
Actual Primary Completion Date
:
Aug 20, 2021
Actual Study Completion Date
:
Aug 20, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence I
|
Drug: DA-2811
single dose administration (one tablet once a day)
Drug: DA-2811-R
single dose administration (one tablet once a day)
|
| Experimental: Sequence II
|
Drug: DA-2811
single dose administration (one tablet once a day)
Drug: DA-2811-R
single dose administration (one tablet once a day)
|
Outcome Measures
Primary Outcome Measures
- AUClast [pre-dose~48 hours post-dose]
Area under the plasma concentration-time curve from time zero to time the last quantifiable time
- Cmax [pre-dose~48 hours post-dose]
Maximum plasma concentration
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy male and/or female subjects
-
BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
-
Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress
Exclusion Criteria:
- Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Gyeonggi-do | Seongnam-si | Korea, Republic of |
Sponsors and Collaborators
- Dong-A ST Co., Ltd.
Investigators
- Principal Investigator: Chung JaeYong, Seoul National University Bundang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04938752
Other Study ID Numbers:
- DA2811_BE2_I
First Posted:
Jun 24, 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