| Trial ID: | L5509 |
| Source ID: | NCT05875259
|
| Associated Drug: |
Br1019-1
|
| Title: |
A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: BR1019-1|DRUG: BR1019-2|DRUG: BR1019-1 + BR1019-2
|
| Outcome Measures: |
Primary: AUC0-24,ss, Area under the concentration-time curve from 0 h to 24 h of BR1019-1 and BR1019-2 at steady-state, 0-48 hours after administration|Cmax,ss, Maximum concentration of drug in plasma of BR1019-1 and BR1019-2 at steady-state, 0-48 hours after administration |
|
| Sponsor/Collaborators: |
Sponsor: Boryung Pharmaceutical Co., Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-05-13
|
| Completion Date: |
2023-06-29
|
| Results First Posted: |
|
| Last Update Posted: |
2023-09-28
|
| Locations: |
Inha University Hospital, Incheon, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT05875259
|
