Trial | NCT01478022  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ibuprofen isosorbide ...

  • Study Participants

    12
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.
Study Started
Oct 31
2011
Primary Completion
Mar 31
2016
Study Completion
Mar 31
2016
Last Update
Aug 31
2018

Drug Isosorbide Dinitrate

Isosorbide Dinitrate 10 mgx2, daily, capsules

  • Other names: Diniket 10 mg

Drug Ibuprofen

Ibuprofen 200 mg daily, capsules

  • Other names: Antalgil 200 mg

Other Ibuprofen and Isosorbide Dinitrate combination

Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose

  • Other names: Antalgil 200 mg and Diniket 10 mg

Isosorbide Dinitrate 20 mg Active Comparator

Isosorbide Dinitrate 10 mg b.i.d

Ibuprofen 200 mg Active Comparator

Ibuprofen 200 mg daily, capsule

Isosorbide dinitrate and Ibuprofen Experimental

Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily

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
No Results Posted