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NCT01381640 Clinical Trial

A Study to Compare Two Paracetamol Tablets

Healthy Subjects Clinical Trial

Official title:
A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01381640
Other study ID # A4040689
Secondary ID
Status Withdrawn
Phase Phase 1
First received June 23, 2011
Last updated July 5, 2016
Start date April 2010
Est. completion date May 2010

Study information
Verified date July 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Marketed paracetamol
marketed formulation
• Experimental paracetamol formulation
Experimental formulation

Locations
Country Name City State
United Kingdom Bio-Images Glasgow Scotland
United Kingdom BIO-IMAGES Research Ltd. Glasgow Scotland

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition Baseline to 12 hours post dosing No
Secondary To assess the gastrointestinal transit by qualitative scintigraphic analysis Baseline to 12 hours post dosing No
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