Pharmacokinetic Study to Compare Two Formulations of Paracetamol

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Fever; Headache Disorders; Pain

Treatments: Drug: Paracetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01767428

A1900832

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental Paracetamol Tablet

Experimental group

Description:

Experimental paracetamol tablet (500 milligrams \[mg\]) administered with 240 milliliters (mL) of water.

Treatment:

Drug: Paracetamol

Standard Paracetamol Tablet (500 mg)

Active Comparator group

Description:

Standard paracetamol tablet (500 mg) administered with 240 mL of water.

Treatment:

Drug: Paracetamol