A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Paracetamol 750 mg; Drug: Paracetamol 500 mg; Drug: Paracetamol 1000 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01551797

A2750894

Details and patient eligibility

About

This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.

Enrollment: 14 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.

Exclusion criteria

• Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).
• Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Test Sustained Release (SR) Paracetamol (2000 mg)

Experimental group

Description:

A single 2000 mg oral dose of SR paracetamol formulation (2 x 1000 mg) administered with 150 mL of water.

Treatment:

Drug: Paracetamol 1000 mg

Test SR Paracetamol (1500 mg)

Experimental group

Description:

A single 1500 mg oral dose of SR paracetamol formulation (2 x 750 mg) administered with 150 mL of water.

Treatment:

Drug: Paracetamol 750 mg

Reference Paracetamol (2000 mg)

Active Comparator group

Description:

Two single 1000 mg doses of paracetamol (2 x 500 mg/dose) administered orally 6 hours apart, administered with 150 mL of water.

Treatment:

Drug: Paracetamol 500 mg