Status:
COMPLETED
To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20
Lead Sponsor:
Parent Project, Italy
Conditions:
Duchenne Muscular Dystrophy (DMD)
Eligibility:
All Genders
18-27 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01478022
Start Date
October 1 2011
End Date
March 1 2016
Last Update
August 31 2018
Active Locations (1)
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1
Clinical Phase 1 Unit - Luigi Sacco Hospital
Milan, Italy, 20157