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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Bupivacaine HCl metered spray
Bupivacaine HCl, 50 mg/10 mL
Clinical Research Unit
Montreal, Canada
Cmax between 0 hour to 240 hour after study drug administration
Maximum concentration occuring at Tmax
Time frame: From 0 hour to 240 hour after study drug administration
Tmax between 0 hour to 240 hour after study drug administration
Time of maximum observed concentration
Time frame: From 0 hour to 240 hour after study drug administration
AUC last
Area under the concentration time curve from the time of last dosing to the time of last quantifiable concentration (Tlast)
Time frame: From 0 hour to 240 hour after study drug administration
AUC inf
Area under the concentration time curve extrapolated to infinity
Time frame: From 0 hour to 240 hour after study drug administration
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