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A Pharmacokinetic Study of an Experimental Paracetamol Formulation

NCT ID: NCT01476176

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

2009-07-31

Study Completion Date

2009-08-31

Brief Summary

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This PK study is designed to show bioequivalence between the study treatments.

Detailed Description

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Conditions

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Headache, Tension-Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental paracetamol formulation

experimental formulation

Group Type EXPERIMENTAL

Experimental paracetamol

Intervention Type DRUG

experimental paracetamol with caffeine

paracetamol marketed formulation

Paracetamol marketed formulation

Group Type ACTIVE_COMPARATOR

Paracetamol marketed formulation

Intervention Type DRUG

marketed formulation containing caffeine

Interventions

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Experimental paracetamol

experimental paracetamol with caffeine

Intervention Type DRUG

Paracetamol marketed formulation

marketed formulation containing caffeine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer

Exclusion Criteria

\-
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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A2260665

Identifier Type: -

Identifier Source: org_study_id