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A Study to Compare Two Paracetamol Formulations.

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Marketed paracetamol (Drug); Experimental paracetamol formulation (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.

Clinical Details

Official title: A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states

Secondary outcome: Speed of absorption in fasted and semi-fed states

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or female volunteers aged 18-55 years with a body mass index ranging

from 19-28 kilograms per square meter who have given informed consent

Locations and Contacts

MDS Pharma Services ARIZONA, Phoenix, Arizona 85044, United States
Additional Information

Starting date: December 2009
Last updated: November 20, 2014

Page last updated: August 23, 2015

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