drugset / Trial / NCT01551836

At What Time Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations

NCT01551836

Phase 1 Completed 12 enrolled GlaxoSmithKline
RandomizedCrossoverSingle-blind

Summary

This will be a single centre, open label, randomised, two-way crossover study in healthy volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in this study to establish at what time point a therapeutic concentration of paracetamol in the blood is reached. Subjects will attend a screening visit to check if they are eligible for study participation then within 15 days they will check-in to the unit for a stay of approximately 48 hours (hrs). They will be given a single dose of one of the preparations on the first day and then the other preparation on the next day. Regular blood samples will be taken along with other assessments for safety.

Timeline

Start
2009-06
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule

Indications

No indication recorded.