drugset / Trial / NCT01332578

A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies

NCT01332578

Phase 4 Completed 25 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-label

Summary

The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.

Timeline

Start
2011-05
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Oral
Background Phenylephrine Small molecule Oral
Background Vitamin C Other / unclassified Oral

Indications