Clinical trial NCT01478022: To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Duchenne Muscular Dystrophy (DMD)
Keywords: DMD
Duchenne
Muscular Dystrophy
Lead sponsor: Parent Project, Italy
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy free-living
* Males between the age of 18 and 27
* Normal ECG
* Body Mass Index of 19.0-29.0 (Kg/m2)
* Subject healthy in the opinion of the Investigator
* Signed informed consent after verbal and written information

Exclusion Criteria:

* Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
* Any Gastrointestinal conditions which, in the opinion of the Investigator, may interfere with the absorption of the drug or render the subjects unable to take oral medication (gastric ulcer, peptic ulcer, stomach acid, frequent diarrhea, gastrointestinal surgery)
* History of the following cardiac diseases SBP \<120 mmHG or DBP \< 80 mmHg
* Platelet count \< 100000/mm3
* History of recurrent headache
* History of ongoing or clinically relevant glaucoma
* History of alcohol, drug or medication abuse within the past 2 years
* Treatment with norepinephrine, acetylcholine and histamine
* History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
* Participation in another study phase 1 with any investigational product within 6 months of screening

Primary outcomes:
measure: Pharmacokinetic parameter: AUC 0-12
timeFrame: At period I, II and III with 7 days intervals between periods
Secondary outcomes:
measure: C max
timeFrame: At period I, II and III with 7 days intervals between periods
measure: T max
timeFrame: At period I, II and III with 7 days intervals beteween periods
measure: Adverse Events
timeFrame: 9 days
measure: Vital signs
timeFrame: 9 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Clinical Phase 1 Unit - Luigi Sacco Hospital
Study officials:
affiliation: Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano
name: Emilio Clementi
role: PRINCIPAL_INVESTIGATOR
References: