Trials / Completed
CompletedNCT04144192
Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Phase 1, Randomized, Comparative Pharmacokinetic Study of Bolus Intravenous Lidocaine 0.7 mg/kg, Lidocaine Patch 1.8%, and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Scilex Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lidocaine patch 1.8% | |
| DRUG | Lidocaine 5% patch | |
| DRUG | Lidocaine 2% Injectable Solution |
Timeline
- Start date
- 2014-04-28
- Primary completion
- 2014-07-24
- Completion
- 2014-07-24
- First posted
- 2019-10-30
- Last updated
- 2024-05-23
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04144192. Inclusion in this directory is not an endorsement.