Trials / Completed
CompletedNCT03145207
PK and DPK of Lidocaine Dermal Products
Evaluation of Bioavailability of Lidocaine Dermal Products
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults.
Detailed description
This research study is intended to determine the effect of heat on lidocaine patches. This study will use lidocaine patches (brand name and generic patches) that have been approved by the Food and Drug Administration (FDA) and are already sold to customers in the United States, and will not include any placebos.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lidocaine patch | lidocaine patch |
Timeline
- Start date
- 2016-12-14
- Primary completion
- 2019-01-10
- Completion
- 2020-05-15
- First posted
- 2017-05-09
- Last updated
- 2020-07-09
- Results posted
- 2020-06-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03145207. Inclusion in this directory is not an endorsement.