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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01540721
First received: February 23, 2012
Last updated: February 13, 2014
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Drug: Marketed paracetamol
Drug: Experimental paracetamol formulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state [ Time Frame: baseline to 12 hours ] [ Designated as safety issue: No ]
  • Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax [ Time Frame: baseline to 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC) [ Time Frame: baseline to 12 hours ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental paracetamol formulation
Experimental formulation
Drug: Experimental paracetamol formulation
Experimental formulation
Active Comparator: Marketed paracetamol
Marketed formulation
Drug: Marketed paracetamol
marketed formulation

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01540721     History of Changes
Other Study ID Numbers: A2750605
Study First Received: February 23, 2012
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
paracetamol
pharmacokinetics

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

ClinicalTrials.gov processed this record on April 16, 2014