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. 2017 Mar 2;56(10):1245–1253. doi: 10.1007/s40262-017-0516-6

Table 2.

Summary of the studies included in the population PK analysis

Study Phase n a No. of CdA samplesb No. of CAde samplesb Treatment: administration and dose (cumulative)
Plasma Urine Plasma Urine
25803 I 16 404 166 189 89 CdA: 3 mg IV infusion/10 mg single oral doses
26127 I 16 416 CdA: 10 mg single oral doses
26486 I 16 419 CdA: 1.75 mg/kg orally over 8 weeks + IFNβ-1a
25643 III 125 470 466 CdA: 3.5 or 5.25 mg/kg orally over 2 years

PK pharmacokinetic, CdA cladribine, CAde 2-chloroadenine, IV intravenous, IFN interferon, RRMS relapsing-remitting multiple sclerosis

aNumber of CdA-treated RRMS patients included in the population PK analysis

bTotal number of samples available for the population PK analysis