At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 14 enrolled
Drug / intervention
Lidocaine patchdrug
Likely dose
Lidocaine patch; specific dose/concentration not specified in eligibility or intervention textAI-extracted
Key inclusion· 9
- ✓Age 18–45 years old, any ethnic background
- ✓Non-smoker (no nicotine-containing substances for ≥2 months)
- ✓Volar forearm ≥24 cm in length with sufficient space for patch placement (≥5 cm above wrist, ≥0.5 cm below antecubital fossa)
- ✓Upper arms ≥28 cm circumference to accommodate two 140 cm² patches on one arm or one on each arm
Key exclusion· 17
- ✕Pregnant, lactating, or positive pregnancy test at enrollment or on study session mornings
- ✕Current smoker or smoked within 2 months
- ✕Participation in any ongoing investigational drug trial or clinical drug trial
- ✕History of chronic obstructive pulmonary disease, cor pulmonale, substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Bioavailability of Lidocaine Dermal Products
In Brief
A Early Phase 1 clinical trial evaluating Lidocaine patch for Heat Effect. Completed, enrolled 14 participants across 1 site.
Detailed Summary
This is a bioequivalence study to compare lidocaine release between a brand name and generic skin patches in healthy adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeat Effect
CountriesUnited States
CollaboratorsFood and Drug Administration (FDA)
Timeline
Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartDec 2016
First PostedMay 2017
Primary CompletionJan 2019
Study CompletionMay 2020
TodayJul 2026
First PostedMay 9, 2017
Enrollment StartDec 14, 2016
Primary CompletionJan 10, 2019
Study CompletionMay 15, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.1 years ago
Interventions
Lidocaine patchdrug
lidocaine patch