Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

Scilex

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lidocaine patch 1.8%; Drug: Lidocaine 5% patch; Drug: Lidocaine 2% Injectable Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04144192

SCI-LIDO-PK-001

Details and patient eligibility

About

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).

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be healthy based on by medical history, laboratory work, and physical exam
• Be at least 18 years of age to 65 years of age
• If childbearing potential, use of acceptable form of birth control
• In the case of females of childbearing potential, have a negative serum pregnancy test

Exclusion criteria

• Use of a prescription medication within 14 days or over-the-counter products within 7 days prior to administration of study medication
• Known hypersensitivity or allergy to any of the components of the lidocaine topical system formulation
• Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Lidocaine Patch (Sequence AB)

Experimental group

Description:

Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15.

Treatment:

Drug: Lidocaine 5% patch

Drug: Lidocaine patch 1.8%

Drug: Lidocaine 2% Injectable Solution

Lidocaine Patch (Sequence BA)

Experimental group

Description:

Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15.

Treatment:

Drug: Lidocaine 5% patch

Drug: Lidocaine patch 1.8%

Drug: Lidocaine 2% Injectable Solution