Pharmacokinetic Study to Compare Two Formulations of Paracetamol

Phase 1CompletedNCT01767428

GlaxoSmithKline30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fever Headache Disorders Pain

Interventions

ParacetamolDRUG

500 mg immediate release paracetamol formulations

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

AUC (0-inf)

Area under the plasma concentration time curve from zero and extrapolated to infinite time.

Time frame: 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.

Cmax

Maximum plasma concentration of paracetamol.

Time frame: 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.

AUC (0-t)

Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.

Time frame: 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.

Secondary Outcomes

Tmax

Time taken to reach maximum plasma concentration of paracetamol.

Time frame: 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.

Data from ClinicalTrials.gov

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