To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20 (ISOFEN1)

Parent Project, Italy

Status and phase: Completed; Phase 1

Conditions: Duchenne Muscular Dystrophy (DMD)

Treatments: Other: Ibuprofen and Isosorbide Dinitrate combination; Drug: Ibuprofen; Drug: Isosorbide Dinitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01478022

ISOFEN1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 27 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Isosorbide Dinitrate 20 mg

Active Comparator group

Description:

Isosorbide Dinitrate 10 mg b.i.d

Treatment:

Drug: Isosorbide Dinitrate

Ibuprofen 200 mg

Active Comparator group

Description:

Ibuprofen 200 mg daily, capsule

Treatment:

Drug: Ibuprofen

Isosorbide dinitrate and Ibuprofen

Experimental group

Description:

Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily

Treatment:

Other: Ibuprofen and Isosorbide Dinitrate combination