Testing Experimental Medication in Healthy Subjects

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.

Pharmaceutical medication involved
Patients and healthy individuals accepted

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 (Ofirmev®) in Healthy Volunteers