Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients

PHASE4RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 5, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Diabetes
Interventions
DRUG

The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach.

Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin were provided by the Department of Pharmacy, Peking University Third Hospital, and were dissolved and mixed with normal saline respectively, and the mixing process needed to be fully stirred. Then, according to the concentration of the drug mixed solution, the corresponding volume of mixed solution was given to achieve the dosage of 10 μg midazolam, 375 μg dabigatran etexilate,10 μg pitavastatin, 50 μg rosuvastatin and 100 μg atorvastatin. In order to avoid the food effect, the test drugs were administered on an empty stomach on the administration day in this experiment.

Trial Locations (1)

100191

RECRUITING

Peking University Third Hospital, Beijing

All Listed Sponsors
lead

Peking University Third Hospital

OTHER