A Pharmacokinetic Study of an Experimental Paracetamol Formulation

Headache, Tension-Type Clinical Trial

Official title:

A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476176
• Other study ID #: A2260665
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2011
• Last updated: November 20, 2014
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: June 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This PK study is designed to show bioequivalence between the study treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy volunteer

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Headache, Tension-Type
• Tension-Type Headache

Intervention

Drug:
• Experimental paracetamol
experimental paracetamol with caffeine
• Paracetamol marketed formulation
marketed formulation containing caffeine

Locations

Country	Name	City	State
United States	MDS Pharma Services ARIZONA	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence		10 hours	No
Secondary	PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)		10 hours	No