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

NCT01540734 | Completed Phase 1

• 1 other identifier: A2750606
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A single dose pharmacokinetic study investigating two paracetamol formulations

Conditions

Healthy Subjects

Keywords

paracetamol; pharmacokinetic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)

  Visit 1 through Visit 3 (Day 13)

Study Arms (2)

Marketed paracetamol

ACTIVE COMPARATOR

marketed formulation

Drug: Marketed paracetamol

Experimental paracetamol formulation

EXPERIMENTAL

Experimental formulation

Drug: Experimental paracetamol formulation

Interventions

Marketed paracetamol DRUG

Marketed formulation

Marketed paracetamol

Experimental paracetamol formulation DRUG

Experimental formulation

Experimental paracetamol formulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

MDS Pharma Services NEBRASKA

Lincoln, Nebraska, 68501, United States

Location

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: December 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 24, 2014

Record last verified: 2014-06

Locations

US (1)