| Trial ID: | L2098 |
| Source ID: | NCT06289920
|
| Associated Drug: |
Br3005
|
| Title: |
A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: BR3005|DRUG: BR3005-1|DRUG: BR3005-2
|
| Outcome Measures: |
Primary: AUCĪ, Area under the Plasma Concentration-Time Curve During a Dosing Interval (tau), 0~48 hours after administration|Cmax, Maximum Concentration of Drug in Plasma, 0~48 hours after administration |
|
| Sponsor/Collaborators: |
Sponsor: Boryung Pharmaceutical Co., Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
47
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-03-02
|
| Completion Date: |
2024-03-28
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-24
|
| Locations: |
Clinical Research Center, H PLUS Yangji Hospital, Seoul, Gwanakgu, 08779, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT06289920
|
