A Study to Compare Two Paracetamol Formulations. | NCT01592227

Studies
A Study to Compare Two Paracetamol Formulations.

NCT01592227

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 24, 2014Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Pain

Interventions

Marketed paracetamol
Experimental paracetamol formulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Nov 17, 2011

First Submission Date that Met QC Criteria

May 3, 2012

First Posted Date

May 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2014

Last Update Posted Date

Nov 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Marketed paracetamol	Active Comparator	Marketed paracetamol	Drug: Marketed paracetamol
Experimental paracetamol formulation	Experimental	Experimental formulations	Drug: Experimental paracetamol formulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Marketed paracetamol	Drug	Marketed paracetamol	Marketed paracetamol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states		baseline to 10 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Speed of absorption in fasted and semi-fed states		baseline to 10 hours post dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MDS Pharma Services ARIZONA		Phoenix	Arizona	85044	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided