CompletedPhase 1ACTRN12612000871842

Maxigesic Metabolism Study: To describe the metabolism of paracetamol when combined with ibuprofen in healthy adult volunteers.

Single-centre, single-dose, open-label, randomised, cross-over study of the effect of ibuprofen on the oxidative metabolism of paracetamol when administered as a fixed dose combination (Maxigesic) in healthy volunteers under fasting conditions.

Sponsor

AFT Pharmacetuicals Ltd

Enrollment

12 participants

Start Date

Sep 4, 2012

Study Type

Interventional

Conditions

Pharmacokinetics of Maxigesic in Healthy Volunteers.

Summary

This study is designed to assess if ibuprofen changes the metabolic profile of paracetamol when given as a fixed dose combination.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria3

Provide written informed consent
Have Body Mass Index between 18.5 and 30.0 kg/m2
Healthy volunteers as determined by medical history, physical examination, ECG, vital signs and laboratory tests

Exclusion Criteria5

Women who are pregnant or nursing
Women who are unwilling to take adequate contraceptive precaustions or who are unwilling to undergo urine pregnancy testing
History of alcohol or drug abuse or dependency
Have a history of allergy or hypersensitivity to ibuprofen, aspirin, any other NSAID or paracetamol
Have haemopoetic, renal or hepatic disease, immunosupression. Have a history of gastric ulceration, indigestion, stomach pain, GI bleeding or bleeding disorders. Are currently suffering from dehydration from diarrhoea and/or vomiting. Have a history of severe asthma. Have a history of severe hypertension, ventricular tachycardia or other cardiac disease. Have insulin dependent diabetes mellitus.

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Interventions

Intervention: Maxigesic as a single oral dose of two tablets (total dose paracetamol 1000mg and ibuprofen 300mg). Cross-over study with a 7 day washout period between doses. Participants will b

Intervention: Maxigesic as a single oral dose of two tablets (total dose paracetamol 1000mg and ibuprofen 300mg). Cross-over study with a 7 day washout period between doses. Participants will be fasted for at least 10 hours overnight before the administration of the study drug. Standardised meals will be provided from 4 hours after study drug administration. Drinking water will be restricted for 1 hour before and after drug administration (not including the standardised 240mL of water given with the study drug.

Locations(1)

Jordan

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ACTRN12612000871842