A Pharmacokinetic Study of an Experimental Paracetamol Formulation

A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01476176

Enrollment

Registered

2011-11-22

Start date

2009-07-31

Completion date

2009-08-31

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

Headache, Tension-Type

Keywords

Bioequivalence, Pharmacokinetics, Healthy volunteers, paracetamol, caffeine

Brief summary

This PK study is designed to show bioequivalence between the study treatments.

Interventions

DRUGExperimental paracetamol

experimental paracetamol with caffeine

DRUGParacetamol marketed formulation

marketed formulation containing caffeine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteer

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence	10 hours

Secondary

Measure	Time frame
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)	10 hours

Countries

United States

Outcome results

None listed

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