Finding studies
Finding studies
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Lead
Corium Innovations, Inc.
This is a single-dose, single-center, open-label, randomized, parallel relative bioavailability study (4 treatments and 1 period) of 3 test products of a Transdermal Delivery System of Ozanimod (Corplex Ozanimod TDS) with the Reference Listed Drug (Zeposia Capsule 0.92 mg), recruiting around 24 healthy (male: female = 1:1) subjects under fasting conditions. The following goals will be procured through this study: 1. To determine the pharmacokinetic profiles of Ozanimod and its' major metabolites (CC112273 and CC1084037) from the Corplex Ozanimod TDS (OZ-TDS 1, OZ-TDS 2 and OZ-TDS 3 manufactured by Corium Innovations, Inc.) (Test Product 1, Test Product 2 and Test Product 3) and the comparator (Zeposia Capsule 0.92 mg manufactured by Bristol Myers Squibb) (Reference Product) in healthy subjects; 2. To compare the relative bioavailability between the Corplex Ozanimod TDS and the oral capsules in healthy subjects; 3. To compare three formulations of the Corplex Ozanimod TDS in healthy subjects; 4. To determine the safety and tolerability of the Corplex Ozanimod TDS vs the oral capsules in healthy subjects.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
