Healthy Volunteers
Conditions
Brief summary
Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.
Interventions
DRUGCaffeine
probe
DRUGDiclofenac
probe
DRUGEsomeprazole
probe
DRUGMetoprolol
probe
DRUGMidazolam
probe
DRUGDabigatran
probe
DRUGClarithromycin
perpetrator
Sponsors
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Weight at least 50 kg and body mass index 19 - 30 kg m-2 * Normal clinical laboratory profiles * No childbearing potential or use of adequate contraceptive measures
Exclusion criteria
* Blood loss \>300 ml within 2 months prior to the first dosing day * Pregnancy, breastfeeding * Allergy or hypersensitivity to caffeine, diclofenac, esomeprazole, metoprolol, midazolam, dabigatran or clarithromycin or to excipients in the pharmaceutical products * Infection with HIV, HBV or HCV * Participation in the preceding 3 months or concomitantly in any clinical drug study * Suspected current drug or alcohol abuse * History of drug or alcohol abuse. * Concomitant medication with the exception of hormonal contraception. * Positive result in urine test for drug abuse. * Nicotine consumption equivalent to \>5 cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC of dabigatran in plasma | 24 h | Exposure ratio for dabigatran in combination and dabigatran alone |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | 23 days |
Countries
Finland
Outcome results
None listed