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
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