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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Parent Project, Italy.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Parent Project, Italy
ClinicalTrials.gov Identifier:
NCT01478022
First received: November 14, 2011
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Duchenne Muscular Dystrophy (DMD)
Drug: Isosorbide Dinitrate
Drug: Ibuprofen
Other: Ibuprofen and Isosorbide Dinitrate combination
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Parent Project, Italy:

Primary Outcome Measures:
  • Pharmacokinetic parameter: AUC 0-12 [ Time Frame: At period I, II and III with 7 days intervals between periods ] [ Designated as safety issue: No ]
    Area under the time-concentration curve (AUC 0-12) of IBU and ISO given concomitantly compared to AUCs of ISO alone and IBU alone. Time points: = at pre dose, 30, 60, 90, 120, 150, 180, 210, 240 min and 5, 6, 8, 10 and 12 hrs post dose


Secondary Outcome Measures:
  • C max [ Time Frame: At period I, II and III with 7 days intervals between periods ] [ Designated as safety issue: No ]
    C max of IBU and ISO given concomitantly compared to AUCs of ISO alone and IBU alone. Time points: = at pre dose, 30, 60, 90, 120, 150, 180, 210, 240 min and 5, 6, 8, 10 and 12 hrs post dose

  • T max [ Time Frame: At period I, II and III with 7 days intervals beteween periods ] [ Designated as safety issue: No ]
    T max of IBU and ISO given concomitantly compared to AUCs of ISO alone and IBU alone. Time points: = at pre dose, 30, 60, 90, 120, 150, 180, 210, 240 min and 5, 6, 8, 10 and 12 hrs post dose

  • Adverse Events [ Time Frame: 9 days ] [ Designated as safety issue: Yes ]
    Adverse Events registration At visit 2, visit 3 and visit 4

  • Vital signs [ Time Frame: 9 days ] [ Designated as safety issue: Yes ]
    Pulse rate and blood pressure (Diastolic and Systolic) measurements in sitting position at pre-dose, and 1 and 3 hours after study drug intake. Complete physical examination At visit 2, visit 3 and visit 4


Estimated Enrollment: 12
Study Start Date: October 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Isosorbide Dinitrate 20 mg
Isosorbide Dinitrate 10 mg b.i.d
Drug: Isosorbide Dinitrate
Isosorbide Dinitrate 10 mgx2, daily, capsules
Other Name: Diniket 10 mg
Active Comparator: Ibuprofen 200 mg
Ibuprofen 200 mg daily, capsule
Drug: Ibuprofen
Ibuprofen 200 mg daily, capsules
Other Name: Antalgil 200 mg
Experimental: Isosorbide dinitrate and Ibuprofen
Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily
Other: Ibuprofen and Isosorbide Dinitrate combination
Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose
Other Name: Antalgil 200 mg and Diniket 10 mg

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 27 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478022

Contacts
Contact: Emilio Clementi, PhD 39.02.50319621 emilio.clementi@unimi.it
Contact: Bianca Francucci, M.D. 39.02.50319621 francucci.bianca@hsacco.it

Locations
Italy
Clinical Phase 1 Unit - Luigi Sacco Hospital Recruiting
Milan, Italy, 20157
Contact: Emilio Clementi, PhD    39.02.50319621    emilio.clementi@unimi.it   
Contact: Bianca Francucci, M.D.    39.02.50319621    francucci.bianca@hsacco.it   
Sponsors and Collaborators
Parent Project, Italy
Investigators
Principal Investigator: Emilio Clementi Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano
  More Information

No publications provided

Responsible Party: Parent Project, Italy
ClinicalTrials.gov Identifier: NCT01478022     History of Changes
Other Study ID Numbers: ISOFEN1
Study First Received: November 14, 2011
Last Updated: November 22, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Parent Project, Italy:
DMD
Duchenne
Muscular Dystrophy

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Ibuprofen
Isosorbide
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on September 29, 2014