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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476189
• Other study ID #: A2750607
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2011
• Last updated: November 20, 2014
• Start date: November 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

A repeat dose pharmacokinetic study investigating two paracetamol formulations

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 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 Design

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Experimental paracetamol formulation
experimental
• Marketed paracetamol
Marketed paracetamol
• Higher dose marketed paracetamol
Higher dose marketed paracetamol

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	Bioequivalence as measured by Area Under the Curve (AUC)		last 24 hours of dosing	No
Secondary	Time duration at or above minimal therapeutic plasma paracetamol concentration		last 24 hours of dosing	No
Secondary	To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)		last 24 hours of dosing	No
Secondary	Adverse events		Baseline to 72 hours post dosing	Yes