| Trial ID: | L0250 |
| Source ID: | NCT05747768
|
| Associated Drug: |
Midazolam, Dabigatran Etexilate, Pitavastatin, Rosuvastatin And Atorvastatin
|
| Title: |
A Clinical Study to Evaluate the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Healthy Volunteers and Renal Impairment Patients
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin
|
| Outcome Measures: |
Primary: plasma concentration, Baseline and within 24 hours after administration|dialysate concentration, 1 day | Secondary: biomarker concentration, Baseline and within 24 hours after administration|urine concentration, Baseline
|
| Sponsor/Collaborators: |
Sponsor: Peking University Third Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2022-07-15
|
| Completion Date: |
2024-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-02-28
|
| Locations: |
Peking University Third Hospital, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05747768
|
