The Objective of This Study is to Compare the Oral Bioavailability and Characterize the Pharmacokinetic Profile
Status:
Completed
Trial end date:
2016-01-15
Target enrollment:
Participant gender:
Summary
Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period,
Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules
(3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions.
Objective: The objective of this study is to compare the oral bioavailability and
characterize the pharmacokinetic profile of the test formulation relative to that of
reference formulation in healthy, adult, human subjects under fasting conditions and to
assess the bioequivalence.