drugset / Trial / NCT02531971
Fentanyl Patch Pharmacokinetics in Healthy Adults
Phase 4
Completed
24 enrolled
University of Maryland, Baltimore
Food and Drug Administration (FDA) · collab
RandomizedCrossoverOpen-labelOther
Summary
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery comparisons between RLD (reference listed drug) Duragesic ® TDDS (transdermal drug delivery system) and Generic Fentanyl TDDS in healthy adults and to ensure safety of individuals utilizing these types of products.
Timeline
- Start
- 2016-01-14
- Primary completion
- 2018-10-16
- Completion
- 2018-10-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 25 ug | Other |
| Comparator | Fentanyl | Other / unclassified | 100 ug | Intravenous |
Indications
No indication recorded.