“A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers”
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
Drug - Pregabalin 100mg
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.
Drug - Acetaminophen 1300mg
Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Pregabalin and Acetaminophen (OfirmevÂ®) in Healthy Volunteers