This is a Phase 1, single center, randomized, two-period crossover study in healthy male and female subjects designed to evaluate the relative bioavailability (BA) and safety at steady state of two formulations of nimodipine: GTX 104 (nimodipine for intravenous \[IV\] infusion; test formulation) and nimodipine oral capsules, RS (reference formulation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
new formulation of nimodipine injection for IV infusion
Nimodipine capsules (reference formulation)
Clinical Research Unit
Montreal, Canada
Cmax Day 1
Maximum concentration
Time frame: Day 1 for the first dose (8:00 AM dose)
AUC (AUCDay 3, 0-24hr)
Area under the concentration-time curve
Time frame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr
Cmax Day 3 across all 6 doses
Maximum concentration across all doses
Time frame: Day 3
Absolute bioavailability (F) Day 3
the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Treatment-1 and Treatment-2 for the ln-transformed parameters Cmax Day3
Time frame: Day 3
Total body clearance of the drug from plasma after IV infusion (CL) Day 3
(Dosedaily/AUCDay3,0-24)
Time frame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3
Dosedaily/AUCDay 3 0-24
Time frame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
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