A Randomized, Open-label, Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection - betamethasone and an Oral Solution of Betamethasone in Healthy Subjects. Four groups of subjects will receive 2 treatments each and randomized in 2-way crossover.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 fast
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered in Period 1 and Period 2 slow
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered in Period 1 and Period 2 fast
Clinical Research Unit
Toronto, Ontario, Canada
AUC from 0 to 72 hours post-dose
Area under the curve
Time frame: Up to 72 hours post-dose
AUC
Area under the curve
Time frame: Up to infinity
Cmax from 0 to 72 hours post-dose
Maximum concentration
Time frame: Up to 72 hours post-dose
Adverse Events from Day 1 to Day 45
Adverse events
Time frame: Day 1 to Day 45
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Area under the curve (AUC0-t)
Time frame: Up to 72 hours post-dose
Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection
Area under the curve (AUC0-inf)
Time frame: Up to infinity
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GTX-102 Betamethasone oral spray high dose (0.025 mg/kg) administered in Period 1 and Period 2 fast
reference product 0.1 mg/kg betamethasone solution as an intramuscular injection
Comparator product 0.1 mg/kg betamethasone oral drops solution