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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isosorbide Dinitrate 20 mg | Active Comparator | Isosorbide Dinitrate 10 mg b.i.d |
|
| Ibuprofen 200 mg | Active Comparator | Ibuprofen 200 mg daily, capsule |
|
| Isosorbide dinitrate and Ibuprofen | Experimental | Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosorbide Dinitrate | Drug | Isosorbide Dinitrate 10 mgx2, daily, capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter: AUC 0-12 | 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 | At period I, II and III with 7 days intervals between periods |
| Measure | Description | Time Frame |
|---|---|---|
| C max | 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 | At period I, II and III with 7 days intervals between periods |
| T max |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilio Clementi | Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Phase 1 Unit - Luigi Sacco Hospital | Milan | 20157 | Italy |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| D009136 | Muscular Dystrophies |
| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D007548 | Isosorbide Dinitrate |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D007547 | Isosorbide |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Ibuprofen | Drug | Ibuprofen 200 mg daily, capsules |
|
|
| Ibuprofen and Isosorbide Dinitrate combination | Other | Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose |
|
|
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 |
| At period I, II and III with 7 days intervals beteween periods |
| Adverse Events | Adverse Events registration At visit 2, visit 3 and visit 4 | 9 days |
| Vital signs | 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 | 9 days |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Organic Chemicals |
| D002241 | Carbohydrates |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |