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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Parent Project, Italy
• Treatments: Ibuprofen; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

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