NCT01592227

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
Last Updated

November 24, 2014

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

November 17, 2011

Last Update Submit

November 20, 2014

Conditions

Pain

Keywords

healthy volunteerpharmacokineticsparacetamol

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states

    baseline to 10 hours post dose

Secondary Outcomes (1)

  • Speed of absorption in fasted and semi-fed states

    baseline to 10 hours post dose

Study Arms (2)

Marketed paracetamol

ACTIVE COMPARATOR

Marketed paracetamol

Drug: Marketed paracetamol

Experimental paracetamol formulation

EXPERIMENTAL

Experimental formulations

Drug: Experimental paracetamol formulation

Interventions

Marketed paracetamolDRUG

Marketed paracetamol

Marketed paracetamol
Experimental paracetamol formulationDRUG

Experimental paracetamol formulation

Experimental paracetamol formulation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services ARIZONA

Phoenix, Arizona, 85044, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

May 7, 2012

Study Start

December 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 24, 2014

Record last verified: 2014-06

Locations

US(1)