Clinical Trial

Testing Experimental Medication in Healthy Subjects

Study Description

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted 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.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT04265456

ParticipAid ID

bkRyra