MedTrace Logo

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

NCT01478022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-08-31

No results posted yet for this study

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.

Conditions

  • Duchenne Muscular Dystrophy (DMD)

Interventions

DRUG

Isosorbide Dinitrate

Isosorbide Dinitrate 10 mgx2, daily, capsules

DRUG

Ibuprofen

Ibuprofen 200 mg daily, capsules

OTHER

Ibuprofen and Isosorbide Dinitrate combination

Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose

Sponsors & Collaborators

  • Parent Project, Italy

    lead OTHER

Principal Investigators

  • Emilio Clementi · Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
27 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478022 on ClinicalTrials.gov