NCT01478022

To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Parent Project, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 27 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Duchenne Muscular Dystrophy (DMD)

Interventions

Type	Name	Description
DRUG	Isosorbide Dinitrate	Isosorbide Dinitrate 10 mgx2, daily, capsules
DRUG	Ibuprofen	Ibuprofen 200 mg daily, capsules
OTHER	Ibuprofen and Isosorbide Dinitrate combination	Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2011-11-23
• Last updated: 2018-08-31

Locations

1 site across 1 country: Italy