Document Classification

Section Type: RESULTS

Text: The ratios of least square means (90 % CI) of pharmacokinetic parameters in the presence and absence of ketoconazole for SPP301 and its metabolite were C (max) (maximum plasma concentration) 1. 22 (1. 13, 1. 32) and 1. 2 (1. 05, 1. 37), AUC (0-infinity) (area under the plasma concentration-time curve from time zero to infinity) 3. 16 (2. 84, 3. 51) and 3. 14 (2. 49, 3. 70) and t1/2 (apparent terminal half-life) 2. 21 (1. 55, 2. 87) and 2. 00 (1. 17, 2. 84), i. e. an increase of systemic exposure by a factor of 3. 2, with individual exposures increasing up to 5. 9-fold.