At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
afatinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone Compared to Concomitant and Timed Administration of Multiple Oral Doses of Ritonavir - an Open-label, Randomised, Three-way Crossover Trial in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating afatinib and ritonavir + afatinib for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedSep 2011
Primary CompletionDec 2011
TodayJul 2026
First PostedSep 1, 2011
Enrollment StartAug 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.8 years ago
Interventions
afatinibdrug
standard therapeutic dose
ritonavir + afatinibdrug
simultaneous intake of ritonavir and afatinib on second treatment day
ritonavir + afatinibdrug
on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet