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A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations

NCT ID: NCT01476189

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

2009-11-30

Study Completion Date

2009-12-31

Brief Summary

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A repeat 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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Experimental paracetamol formulation

test formulation

Group Type EXPERIMENTAL

Experimental paracetamol formulation

Intervention Type DRUG

experimental

Marketed paracetamol

Marketed paracetamol

Group Type ACTIVE_COMPARATOR

Marketed paracetamol

Intervention Type DRUG

Marketed paracetamol

Higher dose marketed paracetamol

higher dose marketed paracetamol

Group Type ACTIVE_COMPARATOR

Higher dose marketed paracetamol

Intervention Type DRUG

Higher dose marketed paracetamol

Interventions

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Experimental paracetamol formulation

experimental

Intervention Type DRUG

Marketed paracetamol

Marketed paracetamol

Intervention Type DRUG

Higher dose marketed paracetamol

Higher dose marketed paracetamol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Good general health 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 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 (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
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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A2750607

Identifier Type: -

Identifier Source: org_study_id