Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 14, 2011
November 22, 2011
October 2011
March 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01478022 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Duchenne Muscular Dystrophy (DMD)
  • Drug: Isosorbide Dinitrate
    Isosorbide Dinitrate 10 mgx2, daily, capsules
    Other Name: Diniket 10 mg
  • Drug: Ibuprofen
    Ibuprofen 200 mg daily, capsules
    Other Name: Antalgil 200 mg
  • 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
  • Active Comparator: Isosorbide Dinitrate 20 mg
    Isosorbide Dinitrate 10 mg b.i.d
    Intervention: Drug: Isosorbide Dinitrate
  • Active Comparator: Ibuprofen 200 mg
    Ibuprofen 200 mg daily, capsule
    Intervention: Drug: Ibuprofen
  • Experimental: Isosorbide dinitrate and Ibuprofen
    Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily
    Intervention: Other: Ibuprofen and Isosorbide Dinitrate combination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 27 Years
Yes
Contact: Emilio Clementi, PhD 39.02.50319621 emilio.clementi@unimi.it
Contact: Bianca Francucci, M.D. 39.02.50319621 francucci.bianca@hsacco.it
Italy
 
NCT01478022
ISOFEN1
Yes
Parent Project, Italy
Parent Project, Italy
Not Provided
Principal Investigator: Emilio Clementi Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano
Parent Project, Italy
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP