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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01476215

First received: November 3, 2011

Last updated: January 24, 2013

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 3, 2011

Last Updated Date

January 24, 2013

Start Date ^ICMJE

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to plasma level above therapeutic level [ Time Frame: baseline to 8 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01476215 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

General PK parameters (e.g. AUC, Tmax, Cmax) [ Time Frame: baseline to 8 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Paracetamol fast dissolution suspension
Drug: Paracetamol medium dissolution suspension
Drug: Paracetamol slow dissolution suspension
Drug: Paracetamol

Study Arm (s)

Experimental: Fast dissolution suspension
Intervention: Drug: Paracetamol fast dissolution suspension
Experimental: Medium dissolution suspension
Intervention: Drug: Paracetamol medium dissolution suspension
Experimental: Slow dissolution suspension
Intervention: Drug: Paracetamol slow dissolution suspension
Active Comparator: Marketed suspension
Intervention: Drug: Paracetamol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy volunteer
Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive

Gender

Male

Ages

19 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01476215

Other Study ID Numbers ^ICMJE

A3950669

Has Data Monitoring Committee

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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