Sex Differences in Berberine Pharmacokinetics

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 5, 2023

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Pharmacokinetic Study in Healthy Volunteers
Interventions
DIETARY_SUPPLEMENT

Berberine

A single dose of 1000 mg berberine in two capsules will be administered with 250 ml of still water in the overnight fasting condition. A total of 11 blood samples will be taken at defined time points (baseline, 1; 1.5; 2; 3; 4; 5; 6; 8; 10; 24 h). At each time point, blood will be collected in 2x 7.5 ml tubes for collecting serum and plasma samples to determine berberine concentrations. (Women will undergo the Intervention twice, once in the 1st half and once in the 2nd half of their menstrual cycle.) In addition urine will be collected over the time of 0-10 h after berberine intake and body composition will be measured by bioelectrical impedance analysis (BIA).

Trial Locations (1)

17489

Center of Drug Absorption and Transport (C_DAT), Greifswald

All Listed Sponsors
lead

University Medicine Greifswald

OTHER

NCT05845931 - Sex Differences in Berberine Pharmacokinetics | Biotech Hunter | Biotech Hunter