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Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend

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ClinicalTrials.gov Identifier: NCT01540721
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Marketed paracetamol Drug: Experimental paracetamol formulation Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations
Study Start Date : December 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: Experimental paracetamol formulation
Experimental formulation
Drug: Experimental paracetamol formulation
Experimental formulation
Active Comparator: Marketed paracetamol
Marketed formulation
Drug: Marketed paracetamol
marketed formulation



Primary Outcome Measures :
  1. Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state [ Time Frame: baseline to 12 hours ]
  2. Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax [ Time Frame: baseline to 12 hours ]

Secondary Outcome Measures :
  1. To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC) [ Time Frame: baseline to 12 hours ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

  • Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540721


Locations
United States, Nebraska
MDS Pharma Services NEBRASKA
Lincoln, Nebraska, United States, 68501
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01540721     History of Changes
Other Study ID Numbers: A2750605
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: June 2014

Keywords provided by GlaxoSmithKline:
paracetamol
pharmacokinetics

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics