To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20
NCT ID: NCT01478022
Last Updated: 2018-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2011-10-31
2016-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Isosorbide Dinitrate 20 mg
Isosorbide Dinitrate 10 mg b.i.d
Isosorbide Dinitrate
Isosorbide Dinitrate 10 mgx2, daily, capsules
Ibuprofen 200 mg
Ibuprofen 200 mg daily, capsule
Ibuprofen
Ibuprofen 200 mg daily, capsules
Isosorbide dinitrate and Ibuprofen
Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily
Ibuprofen and Isosorbide Dinitrate combination
Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose
Interventions
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Isosorbide Dinitrate
Isosorbide Dinitrate 10 mgx2, daily, capsules
Ibuprofen
Ibuprofen 200 mg daily, capsules
Ibuprofen and Isosorbide Dinitrate combination
Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
27 Years
ALL
Yes
Sponsors
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Parent Project, Italy
OTHER
Responsible Party
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Principal Investigators
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Emilio Clementi
Role: PRINCIPAL_INVESTIGATOR
Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano
Locations
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Clinical Phase 1 Unit - Luigi Sacco Hospital
Milan, , Italy
Countries
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Other Identifiers
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ISOFEN1
Identifier Type: -
Identifier Source: org_study_id
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