Healthy volunteers
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: o Healthy volunteers o 18-40 years of age o Body mass index (BMI) 19-30 kg/m2 o Systolic blood pressure 95–140 mmHg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Diastolic blood pressure over 90 mmHg o Any continuous medication (hormonal intrauterine device is permitted) o Any significant medical condition o Insensitivity to rifampicin o Pregnancy and lactation o Previous difficult venipuncture o Alcohol and medicine abuse and drug use o Participation to any other pharmaceutical trial within on month of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study how PXR activation by rifampicin affects blood pressure regulation. ;Secondary Objective: ;Primary end point(s): Changes in 24-hr ambulatory systolic and diastolic blood pressure and pulse. Changes in office systolic and diastolic blood pressure and pulse.;Timepoint(s) of evaluation of this end point: At the end of both arms on Day 8 after the one-week treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Plasma renin activity and serum aldosterone level.;Timepoint(s) of evaluation of this end point: At the end of both arms on Day 9. | — |
Countries
Finland
Contacts
Oulu University Hospital, Department of Internal Medicine