A Study to Compare Two Paracetamol Tablets | NCT01381640

Studies
A Study to Compare Two Paracetamol Tablets

NCT01381640

Sponsor

GlaxoSmithKline

Status

Withdrawn

Last Update Posted

Jul 6, 2016Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

Marketed paracetamol
Experimental paracetamol formulation

Countries

United Kingdom

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was cancelled prior to enrolling any subjects.

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

May 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

Jun 23, 2011

First Submission Date that Met QC Criteria

Jun 23, 2011

First Posted Date

Jun 27, 2011Estimated

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

Jul 5, 2016

Last Update Posted Date

Jul 6, 2016Estimated

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

This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two 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

0Actual

Arms/Interventions Module

Arm Groups

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

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition		Baseline to 12 hours post dosing

Secondary Outcomes

Measure	Description	Time Frame
To assess the gastrointestinal transit by qualitative scintigraphic analysis		Baseline to 12 hours post dosing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects who are in good general health
Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period

Accepts Healthy Volunteers

Yes

Sex

Male

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
BIO-IMAGES Research Ltd.		Glasgow	Scotland	G63 0BX	United Kingdom
Bio-Images