drugset / Trial / NCT01396265
Drug Interaction Study With Rifampicin and Afatinib
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers
Timeline
- Start
- 2011-07
- Primary completion
- 2011-08
- Completion
- —
Outcome
Missed primary endpoint
registry analysis (non-inferiority or equivalence test); Afatinib vs Afatinib + Rifa; Geometric mean ratio 66.20 (90% CI 60.815 to 72.057); ANOVA NCT01396265 ↗
registry analysis (non-inferiority or equivalence test); Afatinib vs Afatinib + Rifa; Geometric mean ratio 66.18 (90% CI 60.656 to 72.213); ANOVA NCT01396265 ↗
registry analysis (non-inferiority or equivalence test); Afatinib vs Afatinib + Rifa; Geometric mean ratio 78.41 (90% CI 72.363 to 84.968); ANOVA NCT01396265 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 40 mg | Oral |
| Subject | Rifampicin | Small molecule | — | Oral |
Indications
No indication recorded.