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Clinical Trials/NCT01592227
NCT01592227
Completed
Phase 1

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

GlaxoSmithKline1 site in 1 country30 target enrollmentDecember 2009
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ConditionsPain
InterventionsMarketed paracetamolExperimental paracetamol formulation
DrugsMarketed paracetamolExperimental paracetamol formulation

Overview

Phase
Phase 1
Intervention
Marketed paracetamol
Conditions
Pain
Sponsor
GlaxoSmithKline
Enrollment
30
Locations
1
Primary Endpoint
Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
December 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • Not provided

Arms & Interventions

Marketed paracetamol

Marketed paracetamol

Intervention: Marketed paracetamol

Experimental paracetamol formulation

Experimental formulations

Intervention: Experimental paracetamol formulation

Outcomes

Primary Outcomes

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

Time Frame: baseline to 10 hours post dose

Secondary Outcomes

  • Speed of absorption in fasted and semi-fed states(baseline to 10 hours post dose)

Study Sites (1)

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