Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration

Detailed description:

Arms:
arm 1: 1 tablet afatinib single dose arm 2: 2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day arm 3: 2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day

Interventions: intervention 1: afatinib intervention 2: ritonavir + afatinib intervention 3: ritonavir + afatinib
Intervention descriptions: intervention 1: standard therapeutic dose intervention 2: simultaneous intake of ritonavir and afatinib on second treatment day intervention 3: on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet

Protocol document: