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

A Repeat Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations

A repeat dose pharmacokinetic study investigating two paracetamol formulations

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Marketed paracetamol; Drug: Experimental paracetamol formulation; Drug: Higher dose marketed paracetamol

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68501
      • MDS Pharma Services NEBRASKA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Marketed paracetamol	Drug: Marketed paracetamol; Marketed paracetamol
Experimental: Experimental paracetamol formulation; test formulation	Drug: Experimental paracetamol formulation; experimental
Active Comparator: Higher dose marketed paracetamol; higher dose marketed paracetamol	Drug: Higher dose marketed paracetamol; Higher dose marketed paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence as measured by Area Under the Curve (AUC)	last 24 hours of dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Time duration at or above minimal therapeutic plasma paracetamol concentration	last 24 hours of dosing
To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)	last 24 hours of dosing
Adverse events	Baseline to 72 hours post dosing

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 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: November 17, 2011
• First Posted (Estimate): November 22, 2011

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: pharmacokinetic; steady state; paracetamol; Healthy volunteer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: A2750607