PK Study of 2 Marketed Cold Remedy Formulations containing Paracetamol

• Research type

  Research Study

• Full title

  A Randomised, Two Way Crossover Study to Determine the Time at Which Therapeutic Plasma Concentrations of Paracetamol are Achieved in Two Marketed Formulations

• IRAS ID

  21766

• Eudract number

  2009-012145-32

• Research summary

  This study involves the administration of two marketed cold remedies containing set amounts of paracetamol (750 mg and 1,000 mg given as oral liquid formulations). These formulations give fast and effective relief from major cold anflusymptoms such as fever, shivers, headache, aching limbs, nasal congestion and sore throat pain. The maximum recommended adult dose of paracetomol is 1,000 mg, with 4 hours between doses, and no more than four doses in 24 hours. The study formulations also contain 10 mg of phenylephrine hydrochloride (a decongestant) and up to 60 mg of Vitamin C (a nutrient that's necessary to the body's health) but these ingredients will not be investigated during this study. The purpose of this study is to find out how long it takes from administration of each formulation for the amount of paracetamol in the blood to reach a set level. This will give an idea as to how long it will take for the paracetamol to start working in someone with cold anflusymptoms. A total of 12 male volunteers (aged between 18-55 years) will take part in this study. Volunteers will stay in the clinic for 2 nights and will receive each of the 2 formulations once on 2 separate occasions during the study. There will be an interval of at least 24 hours between the two doses. The maximum duration of the study from the first screening visit until leaving the clinic on Day 2 could be up to 17 days for each volunteer.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/3

• Date of REC Opinion

  14 May 2009

• REC opinion

  Favourable Opinion