Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measurement of Maximum Serum Concentration of Lidocaine (Cmax)Primary· For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Cmax is the highest lidocaine concentration measured in the serum.
Lidocaine 5% patch
Group
Value
95% CI
All Study Participants
113.95
± 38.84
Lidoderm® 5% patch
Group
Value
95% CI
All Study Participants
123.54
± 68.97
Intravenous lidocaine hydrochloride
Group
Value
95% CI
All Study Participants
706.15
± 338.86
Measurement of Volume of Lidocaine Distribution (V)Secondary· For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Volume of distribution is a mathematical concept that relates the amount of lidocaine in the body to the concentration of lidocaine measured in the serum.
Lidocaine 5% patch
Group
Value
95% CI
All Study Participants
5.13
± 2.07
Lidoderm® 5% patch
Group
Value
95% CI
All Study Participants
5.15
± 2.13
Intravenous lidocaine hydrochloride
Group
Value
95% CI
All Study Participants
1.98
± 0.68
Measurement of Time of Maximum Serum Lidocaine Concentration (Tmax).Secondary· For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Tmax is the time point at which the maximum drug concentration in serum is measured.
Lidocaine 5% patch
Group
Value
95% CI
All Study Participants
9.08
± 2.90
Lidoderm® 5% patch
Group
Value
95% CI
All Study Participants
10.82
± 2.2
Intravenous lidocaine hydrochloride
Group
Value
95% CI
All Study Participants
0.03
± 0
Measurement of Elimination Rate Constant of Lidocaine (Kel)Secondary· For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
The elimination rate constant is a mathematical value describing the rate at which lidocaine is removed from the body.
Lidocaine 5% patch
Group
Value
95% CI
All Study Participants
0.17
± 0.06
Lidoderm® 5% patch
Group
Value
95% CI
All Study Participants
0.19
± 0.12
Intravenous lidocaine hydrochloride
Group
Value
95% CI
All Study Participants
0.31
± 0.1
Determination of Area Under the Serum-concentration-time Curve (AUC)Secondary· For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Area under the serum-concentration-time curve is a mathematical measure of total systemic exposure to lidocaine in the body.
Lidocaine 5% patch
Group
Value
95% CI
All Study Participants
807.32
± 285.31
Lidoderm® 5% patch
Group
Value
95% CI
All Study Participants
748.55
± 420.93
Intravenous lidocaine hydrochloride
Group
Value
95% CI
All Study Participants
671.07
± 165.01
Residual Drug Analysis in Worn TDDS and PatchesSecondary· Measured after patches are removed from subjects following 12 hours of patch wear.
The amount of drug remaining in the patches is measured after the patches have been worn and removed. This outcome is only reported for the patch arms of the study and is not applicable to the intravenous arm.
Lidocaine 5% patch
Group
Value
95% CI
All Study Participants
123.79
± 6.58
Lidoderm® 5% patch
Group
Value
95% CI
All Study Participants
655.16
± 29.96
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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 of Lidoderm® topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured by Mylan Pharmaceuticals) in healthy adults, and to ensure the safety of individuals utilizing these types of products.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Nicole K Brogden
Last refreshed: 1 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03310970.