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Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®

NCT ID: NCT01540734

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2009-12-31

Brief Summary

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A single dose pharmacokinetic study investigating two paracetamol formulations

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Marketed paracetamol

marketed formulation

Group Type ACTIVE_COMPARATOR

Marketed paracetamol

Intervention Type DRUG

Marketed formulation

Experimental paracetamol formulation

Experimental formulation

Group Type EXPERIMENTAL

Experimental paracetamol formulation

Intervention Type DRUG

Experimental formulation

Interventions

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Marketed paracetamol

Marketed formulation

Intervention Type DRUG

Experimental paracetamol formulation

Experimental formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Good general heatlh with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria

* Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the remainder of the study.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
* Current (within 14 days of screening) or regular use of any prescription, over the counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
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 NEBRASKA

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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A2750606

Identifier Type: -

Identifier Source: org_study_id