drugset
drugset / Trial / NCT04265456

A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers

NCT04265456 ↗

Phase 1 Completed 63 enrolled Nevakar, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2020-01-14
Primary completion
2020-06-15
Completion
2020-07-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1300 mg Intravenous
Subject Pregabalin Small molecule 100 mg Intravenous

Indications

No indication recorded.