Duchenne Muscular Dystrophy (DMD) Clinical Trial
Official title:
Open, Randomized, 3 Period Cross-over Design, in Healthy Volunteers to Compare the Pharmacokinetics Profiles of 3 Treatments: ISO 20, IBU 200 and IBU Plus ISO Combinations (200 + 20) Administered Per os as Single Doses
This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200
and IBU and ISO combinations (200 +20) given in single dose.
This study is being conducted to support the submission for new indication in treatment of
the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular
dystrophy.
This trial is designed to define drug interactions following the combined administration of
Isosorbide Dinitrate, a NO donor, and ibuprofen, NSAID, a through pharmacokinetics approach.
Both ibuprofen and Isosorbide Dinitrate were licensed worldwide. Ibuprofen is approved for
use in adults and children; Isosorbide is approved for use in adults. Ibuprofen is currently
used in pediatric patients as a first line anti-inflammatory and antipyretic agent. Consensus
exists that among NSAIDs ibuprofen is the one endowed with less adverse effects (see note 66
of the Italian Drug Agency AIFA and MEA). No specific studies concerning safety and
tolerability of ISDN in pediatric patients have been reported.
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|---|---|---|---|
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