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Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

NCT04819581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-03-29

No results posted yet for this study

Summary

This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTlido.

Conditions

  • Healthy

Interventions

DRUG

SP-103

lidocaine topical system 5.4%

DRUG

ZTlido

lidocaine topical system 1.8%

Sponsors & Collaborators

  • Scilex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Boldingh, PharmD · AXIS Clinicals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-03
Primary Completion
2019-08-27
Completion
2019-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819581 on ClinicalTrials.gov