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

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

A single dose pharmacokinetic study investigating two paracetamol formulations

Study Overview

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

• 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: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good general heatlh 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 remainder of 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Marketed paracetamol; marketed formulation	Drug: Marketed paracetamol; Marketed formulation
Experimental: Experimental paracetamol formulation; Experimental formulation	Drug: Experimental paracetamol formulation; Experimental formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare bioavailability as measured by Area under the Curve in both fed and fasted states	Visit 1 through Visit 3 (Day 13)
To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax	Visit 1 through Visit 3 (Day 13)

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)	Visit 1 through Visit 3 (Day 13)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 29, 2012

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; paracetamol
• 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: A2750606