Duchenne Muscular Dystrophy (DMD)
Conditions
Keywords
DMD, Duchenne, Muscular Dystrophy
Brief 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.
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.
Interventions
Isosorbide Dinitrate 10 mgx2, daily, capsules
DRUGIbuprofen
Ibuprofen 200 mg daily, capsules
OTHERIbuprofen and Isosorbide Dinitrate combination
Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose
Sponsors
Parent Project, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 27 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter: AUC 0-12 | 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
| Measure | Time frame | Description |
|---|---|---|
| C max | 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 |
| T max | 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 |
| Adverse Events | 9 days | Adverse Events registration At visit 2, visit 3 and visit 4 |
| Vital signs | 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 |
Countries
Italy
Outcome results
None listed