drugset / Trial / NCT01478022
To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-10
- Primary completion
- 2016-03
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ibuprofen | Small molecule | 200 mg | Oral |
| Comparator | Isosorbide Dinitrate | Other / unclassified | 10 mg | Oral |