A Clinical Study to Evaluate the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Healthy Volunteers and Renal Impairment Patients

Summary

1. To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Chinese people with renal impairment; 2. To explore the effect of dialysis on the functional changes of P-gp, CYP3A4, OATP1B and BCRP in patients with end-stage renal disease; 3. Validation of urotoxic molecules as possible biomarkers that can assess intestinal P-gp function.

Timeline

Start

2022-07-15

Primary completion

2024-06-01

Completion

2024-12-31

Drugs

Indications