drugset / Trial / NCT03694587
pK of a Novel 200 mg Ibuprofen Medicated Plaster
Phase 1
Completed
16 enrolled
Medherant Ltd
Cooperative Clinical Drug Research and Development AG (CCDRD AG) · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This is a Phase I study of the pharmacokinetics of a novel 200 mg Ibuprofen Medicated Plaster. The study will be conducted as a monocentric, open, randomised, single and multiple-dose, two-period, crossover trial in healthy volunteers. A total of 16 healthy volunteers will be randomised. A wash-out period of 3 days is planned between the two periods. Each of the volunteers will be randomly assigned to one of 2 possible administration sequences.
Timeline
- Start
- 2018-09-25
- Primary completion
- 2018-10-18
- Completion
- 2018-10-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ibuprofen | Small molecule | 200 mg | Topical |
Indications
No indication recorded.