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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05145621
Study type Interventional
Source Alembic Pharmaceuticals Ltd.
Contact
Status Completed
Phase Phase 1
Start date October 29, 2015
Completion date January 15, 2016

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