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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-28

Study Completion Date

2016-10-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04144192

Healthy

COMPLETED PHASE1

Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% Under Conditions of Heat and Exercise

NCT04150536

Healthy

COMPLETED PHASE1

Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects

NCT04319926

Healthy

COMPLETED PHASE1

Pharmacokinetics of Lidocaine in Healthy Adults

NCT03310970

Healthy

COMPLETED PHASE4

Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects

NCT04320173

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine Patch (Sequence AB)

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.

Group Type EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type DRUG

Lidocaine patch 5%

Intervention Type DRUG

Lidocaine Patch (Sequence BA)

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.

Group Type EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type DRUG

Lidocaine patch 5%

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine topical system 1.8%

Intervention Type DRUG

Lidocaine patch 5%

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lidocaine patch 1.8% ZTlido Lidoderm

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes