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A Study to Compare Two Paracetamol Formulations.

NCT ID: NCT01592227

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Marketed paracetamol

Marketed paracetamol

Group Type ACTIVE_COMPARATOR

Marketed paracetamol

Intervention Type DRUG

Marketed paracetamol

Experimental paracetamol formulation

Experimental formulations

Group Type EXPERIMENTAL

Experimental paracetamol formulation

Intervention Type DRUG

Experimental paracetamol formulation

Interventions

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Marketed paracetamol

Marketed paracetamol

Intervention Type DRUG

Experimental paracetamol formulation

Experimental paracetamol formulation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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MDS Pharma Services ARIZONA

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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A6480791

Identifier Type: -

Identifier Source: org_study_id