Relative Bioavailability of of Olodaterol and Ketoconazole

Summary

This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol

Timeline

Start

2010-05

Primary completion

2010-08

Completion

—

Outcome

Missed primary endpoint

registry Adjusted geometric mean ratio 168.4 (90% CI 155.5 to 182.4); ANOVA; note: P-value for ratio outside interval 0.8-1.25 NCT01153711 ↗

registry Adjusted geometric mean ratio 166.1 (90% CI 153.6 to 179.6); ANOVA; note: P-value for ratio outside 0.8-1.25 NCT01153711 ↗

registry Adjusted geometric mean ratio 106.63 (90% CI 100.211 to 113.463); ANOVA; note: P-value for ratio outside 0.8-1.25 NCT01153711 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketoconazole	Small molecule	400 mg	Oral
Subject	Olodaterol	Small molecule	10 ug	Inhaled

Indications