Maxigesic PE Study: Determining the bioavailaiblity of Maxigesic PE in healthy adult volunteers.

Maxigesic PE Study: Comparative, randomised, single dose, three period, cross-over, open-label study to determine the bioavailability of AFT Pharmaceuticals test product Maxigesic PE relative to reference I Maxigesic and reference II phenylephrine in healthy adult volunteers under fasting conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000860864

Enrollment

Registered

2012-08-15

Start date

2012-08-20

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 describe the pharmacokinetics of Maxigesic PE and identify whether a pharmacokinetic interaction exists between phenylephrine and paracetamol or ibuprofen when given together.

Interventions

Intervention: Maxigesic PE as a single oral dose of two tablets (total dose paracetamol 1000mg, ibuprofen 150mg and phenylephrine 10mg). Cross-over study with 7 day washout period between dosing. Note: Maxigesic PE is the brand name of this product. Each tablet of Maxigesic PE contains 500mg paracetamol, 150mg ibuprofen and 5mg phenylephrine.

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 ang 30.0 kg/m2 3) Healty 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, paracetamol or phenylephrine 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