Pharmacokinetic Study to Compare Two Formulations of Paracetamol

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study

• BMI must be within the range 18.5 - 24.9 kg/m^2

• Participant with a minimum weight of 50 kg

Exclusion Criteria:

• Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)

• Participant with known or suspected intolerance or hypersensitivity to the study materials

• Participant who are vegetarian

• Participant smoking more than five cigarettes a day