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: June 19, 2014
Last verified: February 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 19, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 16, 2014