A Study to Compare Two Paracetamol Formulations.

A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01592227

Enrollment

Registered

2012-05-07

Start date

2009-12-31

Completion date

2009-12-31

Last updated

2014-11-24

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

Conditions

Pain

Keywords

healthy volunteer, pharmacokinetics, paracetamol

Brief summary

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

Interventions

DRUGMarketed paracetamol

Marketed paracetamol

DRUGExperimental paracetamol formulation

Experimental paracetamol formulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

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