Skip to main content
OpenTrials
Completed

NCT Number: NCT01478022

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Duchenne Muscular Dystrophy (DMD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Phase 1 Unit - Luigi Sacco Hospital

Milan, 20157, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isosorbide Dinitrate

Drug

Isosorbide Dinitrate 10 mgx2, daily, capsules

Other names: Diniket 10 mg

Ibuprofen

Drug

Ibuprofen 200 mg daily, capsules

Other names: Antalgil 200 mg

Ibuprofen and Isosorbide Dinitrate combination

Other

Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose

Other names: Antalgil 200 mg and Diniket 10 mg

Primary outcomes

  1. Pharmacokinetic parameter: AUC 0-12

    Time frame: At period I, II and III with 7 days intervals between periods

    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 outcomes

  1. C max

    Time frame: At period I, II and III with 7 days intervals between periods

    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

  2. T max

    Time frame: At period I, II and III with 7 days intervals beteween periods

    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

  3. Adverse Events

    Time frame: 9 days

    Adverse Events registration At visit 2, visit 3 and visit 4

  4. Vital signs

    Time frame: 9 days

    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

Sponsors and collaborators

Lead sponsor

Parent Project, Italy

Other

Registry information

Official study 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

Acronym: ISOFEN1

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 23, 2011
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.