- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592227
A Study to Compare Two Paracetamol Formulations.
November 20, 2014 updated by: GlaxoSmithKline
A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.
A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85044
- MDS Pharma Services ARIZONA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Marketed paracetamol
|
Marketed paracetamol
|
Experimental: Experimental paracetamol formulation
Experimental formulations
|
Experimental paracetamol formulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states
Time Frame: baseline to 10 hours post dose
|
baseline to 10 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Speed of absorption in fasted and semi-fed states
Time Frame: baseline to 10 hours post dose
|
baseline to 10 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
November 17, 2011
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
November 24, 2014
Last Update Submitted That Met QC Criteria
November 20, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6480791
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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