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CompletedPhase 1ACTRN12612000860864

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.

Sponsor

AFT Pharmaceuticals Ltd

Enrollment

30 participants

Start Date

Aug 20, 2012

Study Type

Interventional

Conditions

Pharmacokinetics of Maxigesic PE in Healthy Volunteers

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.

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 ang 30.0 kg/m2
  • Healty 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, paracetamol or phenylephrine
  • 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 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.

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.

Locations(1)

Amman, Jordan

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ACTRN12612000860864