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A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476189
First received: November 17, 2011
Last updated: January 24, 2013
Last verified: December 2012
History of Changes
  Purpose

A repeat dose pharmacokinetic study investigating two paracetamol formulations


Condition Intervention Phase
Healthy Volunteer
 Drug: Experimental paracetamol formulation
Drug: Marketed paracetamol
Drug: Higher dose marketed paracetamol
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Bioequivalence as measured by Area Under the Curve (AUC) [ Time Frame: last 24 hours of dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time duration at or above minimal therapeutic plasma paracetamol concentration [ Time Frame: last 24 hours of dosing ] [ Designated as safety issue: No ]
  • To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel) [ Time Frame: last 24 hours of dosing ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Baseline to 72 hours post dosing ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: November 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
test formulation
 Drug: Experimental paracetamol formulation
experimental
Active Comparator: Marketed paracetamol
Marketed paracetamol
 Drug: Marketed paracetamol
Marketed paracetamol
Active Comparator: Higher dose marketed paracetamol
higher dose marketed paracetamol
 Drug: Higher dose marketed paracetamol
Higher dose marketed paracetamol

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
  • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476189

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: NCT01476189     History of Changes
Other Study ID Numbers: A2750607
Study First Received: November 17, 2011
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
pharmacokinetic
steady state
paracetamol
Healthy volunteer

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 June 18, 2013