Postherpetic Neuralgia
Conditions
Brief 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.
Interventions
DRUGGTX-101
Bupivacaine HCl metered spray
DRUGBupivacaine HCl subcutaneous injection
Bupivacaine HCl, 50 mg/10 mL
Sponsors
Grace Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated informed consent form (ICF) * Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening * Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at Screening * Have no clinically significant diseases captured in the medical/surgical history or evidence of clinically significant findings on the physical examination (including vital signs), weight and/or clinical laboratory tests and/or ECG, as determined by an Investigator
Exclusion criteria
* History of significant hypersensitivity to bupivacaine, local anesthetic agents of amide type, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs * Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects * History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax between 0 hour to 240 hour after study drug administration | From 0 hour to 240 hour after study drug administration | Maximum concentration occuring at Tmax |
| Tmax between 0 hour to 240 hour after study drug administration | From 0 hour to 240 hour after study drug administration | Time of maximum observed concentration |
| AUC last | From 0 hour to 240 hour after study drug administration | Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast) |
| AUC inf | From 0 hour to 240 hour after study drug administration | Area under the concentration time curve extrapolated to infinity |
Countries
Canada
Outcome results
None listed