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Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects

NCT05517486 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-01-23

No results posted yet for this study

Summary

This is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects.

The study will enroll subjects to evaluate the PK of 3 dose strengths (50 mg, 100 mg and 200 mg) of GTX-101 compared to Subcutaneous injection in healthy adult subjects.

Blood samples for PK assessments will be collect at specified time points. Safety assessments will also be performed throughout the study.

Conditions

  • Postherpetic Neuralgia

Interventions

DRUG

GTX-101

Bupivacaine HCl metered spray

DRUG

Bupivacaine HCl subcutaneous injection

Bupivacaine HCl, 50 mg/10 mL

Sponsors & Collaborators

  • Grace Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2022-08-21
Completion
2023-05-03
FDA Drug
Yes

Countries

  • Canada

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 NCT05517486 on ClinicalTrials.gov