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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540721
• Other study ID #: A2750605
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2012
• Last updated: November 20, 2014
• Start date: December 2009
• Est. completion date: December 2009

Study information

• Verified date: June 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Marketed paracetamol
marketed formulation
• Experimental paracetamol formulation
Experimental formulation

Locations

Country	Name	City	State
United States	MDS Pharma Services NEBRASKA	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state		baseline to 12 hours	No
Primary	Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax		baseline to 12 hours	No
Secondary	To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)		baseline to 12 hours	No