Bioequivalence Study of 2 Capsule Formulations of Fingolimod 0.5 mg Assessing Both Parent Drug and Active Metabolite in New Zealand Healthy Subjects (Truncated Design) - Hung, Noelyn Anne; Costa, Fernando Guillermo; Hung, Cheung‐Tak; Rosenberg, Mónica Esther (Clinical pharmacology in drug development, 2020)
Keywords: Administration, Oral; Adult; Area Under Curve; Bioequivalence; Body Mass Index; Cross-Over Studies; Cytochrome P450 Family 4 - metabolism; Drug Compounding - methods; Drug Compounding - statistics & numerical data; Drug dosages; Fasting - metabolism; Female; fingolimod 0.5 mg; Fingolimod Hydrochloride - administration & dosage; Fingolimod Hydrochloride - blood; Fingolimod Hydrochloride - metabolism; Fingolimod Hydrochloride - pharmacokinetics; fingolimod phosphate; healthy adults; Healthy Volunteers - statistics & numerical data; Humans; Male; Middle Aged; Multiple Sclerosis, Relapsing-Remitting - blood; Multiple Sclerosis, Relapsing-Remitting - drug therapy; New Zealand - epidemiology; Pharmacokinetics; Sphingosine 1 Phosphate Receptor Modulators - administration & dosage; Sphingosine 1 Phosphate Receptor Modulators - blood; Sphingosine 1 Phosphate Receptor Modulators - metabolism; Sphingosine 1 Phosphate Receptor Modulators - pharmacokinetics; Therapeutic Equivalency; New Zealand; healthy adults; fingolimod 0.5 mg; bioequivalence; fingolimod phosphate