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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000871842

Enrollment

Registered

2012-08-17

Start date

2012-09-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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

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 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 wi

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1) Provide written informed consent 2) Have Body Mass Index between 18.5 and 30.0 kg/m2 3) Healthy volunteers as determined by medical history, physical examination, ECG, vital signs and laboratory tests

Exclusion criteria

1) Women who are pregnant or nursing 2) Women who are unwilling to take adequate contraceptive precaustions or who are unwilling to undergo urine pregnancy testing 3) History of alcohol or drug abuse or dependency 4) Have a history of allergy or hypersensitivity to ibuprofen, aspirin, any other NSAID or paracetamol 5) 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.

Outcome results