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A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions

NCT ID: NCT01476215

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2009-11-30

Brief Summary

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This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.

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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Fast dissolution suspension

Group Type EXPERIMENTAL

Paracetamol fast dissolution suspension

Intervention Type DRUG

Medium dissolution suspension

Group Type EXPERIMENTAL

Paracetamol medium dissolution suspension

Intervention Type DRUG

Slow dissolution suspension

Group Type EXPERIMENTAL

Paracetamol slow dissolution suspension

Intervention Type DRUG

Marketed suspension

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Interventions

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Paracetamol fast dissolution suspension

Intervention Type DRUG

Paracetamol medium dissolution suspension

Intervention Type DRUG

Paracetamol slow dissolution suspension

Intervention Type DRUG

Paracetamol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer
* Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

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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A3950669

Identifier Type: -

Identifier Source: org_study_id