A Study to Compare Two Paracetamol Tablets

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01381640

Enrollment

Registered

2011-06-27

Start date

2010-04-30

Completion date

2010-05-31

Last updated

2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

paracetamol, healthy volunteer, pharmacoscintography

Brief summary

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

Interventions

DRUGMarketed paracetamol

marketed formulation

DRUGExperimental paracetamol formulation

Experimental formulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026