This is a Phase I, randomised, double-blind, placebo-controlled, 4-way crossover study to investigate the PD effects, safety, tolerability and PK/PD correlation of two single oral dose levels of IP2015 compared to 300 mg pregabalin and placebo in healthy male subjects using the ID capsaicin model.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Pain related assessments of effect
The area of hyperalgesia
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Subjective rating of pain
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Pain VAS score of hyperalgesia
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Area and pain VAS score of brush-evoked allodynia
Time frame: A 6 hours time interval after dosing
Pain related assessments of effect
Area of flare (AF)
Time frame: A 6 hours time interval after dosing
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Comparator