E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers |
Terveitä vapaaehtoisia |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study how PXR activation by rifampicin affects blood pressure regulation. |
Tutkimus selvittää miten rifampisiinin aiheuttama PXR-aktivaatio vaikuttaa verenpaineen säätelyyn. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
o Terveitä vapaaehtoisia
o 18-40 vuotiaita
o Painoindeksi (BMI) 19-30 kg/m2
o Systolinen verenpaine 95–140 mmHg
|
|
E.4 | Principal 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 |
o Diastolinen verenpaine yli 90 mmHg
o Säännöllinen lääkitys (hormonikierukka sallittu)
o Merkittävät sairaudet
o Yliherkkyys rifampisiinille
o Raskaus ja imetys
o Aiemmat vaikeat verinäytteen otot
o Lääkkeiden ja alkoholin väärinkäyttö ja huumeiden käyttö
o Osallistuminen muuhun lääketutkimukseen 1 kk sisällä ennen tutkimuksen alkua
|
|
E.5 End points |
E.5.1 | 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. |
Muutokset 24h-verenpaineseurannassa (systolinen ja diastoline verenpaine ja syke).
Muutokset verenpaineen kertamittauksissa (systolinen ja diastoline verenpaine ja syke) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of both arms on Day 8 after the one-week treatment. |
Jokaisen tutkimushaaran lopussa eli viikon lääkityksen jälkeen päivänä 8. |
|
E.5.2 | Secondary end point(s) |
Plasma renin activity and serum aldosterone level. |
Plasman reniiniaktiivisuus ja seerumin aldosteronitaso |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of both arms on Day 9. |
Kummankin tutkimushaaran lopussa tutkimusjakson päivänä 9. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |