Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects

Scilex

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lidocaine topical system 1.8%; Drug: Lidocaine patch 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04149938

SCI-LIDO-PK-002A

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: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Must be healthy based on medical history, laboratory work, and physical exam
• Be ≥18 and ≤65 years of age
• Females of childbearing potential must not be pregnant and be using an acceptable form of birth control
• Must be free of any systemic or dermatologic disorder

Key Exclusion Criteria:

• Use of prescription medication within 14 days or over-the-counter products within 7 days prior to study medication
• Current use of opioids
• Known hypersensitivity or allergy to any of the components of the product formulations
• 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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54 participants in 2 patient groups

Lidocaine Patch (Sequence AB)

Experimental group

Description:

Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours.

Treatment:

Drug: Lidocaine patch 5%

Drug: Lidocaine topical system 1.8%

Lidocaine Patch (Sequence BA)

Experimental group

Description:

Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours.

Treatment:

Drug: Lidocaine patch 5%

Drug: Lidocaine topical system 1.8%