Pharmacokinetic Study to Compare Two Formulations of Paracetamol

Phase 1

Completed

• Conditions: Pain; Fever; Headache Disorders
• Interventions: Drug: Paracetamol

• Registration Number: NCT01767428
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2012-12-06
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-10
• Last Update Submitted: 2013-01-10
• Study First Posted: 2013-01-14
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Paracetamol Tablet (500 mg)	Paracetamol	Standard paracetamol tablet (500 mg) administered with 240 mL of water.
Experimental Paracetamol Tablet	Paracetamol	Experimental paracetamol tablet (500 milligrams \[mg\]) administered with 240 milliliters (mL) of water.

Primary Outcome Measures

Name	Time	Method
Cmax	Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.	Maximum plasma concentration of paracetamol.
AUC (0-t)	Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.	Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.
AUC (0-inf)	Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.	Area under the plasma concentration time curve from zero and extrapolated to infinite time.

Secondary Outcome Measures

Name	Time	Method
Tmax	Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.	Time taken to reach maximum plasma concentration of paracetamol.