Steady-State Comparative BA Study of Pramipexole at 2 Dose Levels

• Research type

  Research Study

• Full title

  Open-Label, Randomised, Multiple-Dose, Crossover Bioavailability Study of 1.57 mg and 2.1 mg Pramipexole Prolonged-Release Tablets in Healthy Adult Male Volunteers Under Fasting Conditions

• IRAS ID

  102377

• Contact name

  Adrian Johnston Stewart

• Sponsor organisation

  KRKA d.d. Novo mesto

• Eudract number

  2012-003588-23

• Research summary

  The purpose of this study is to compare two new dose (1.57 mg and 2.1 mg) formulations of Pramipexole Prolonged-Release Tablets to currently marketed ones under fasting conditions in healthy male volunteers when given as multiple doses. The study will find out how much of and the rate at which pramipexole gets into and is removed from the body from each of the formulations. To investigate this, volunteers will be titrated up to 1.57 mg using lower doses of pramipexole. They will then take in a randomised order multiple doses of two 1.57 mg formulations followed by multiple doses of two 2.1 mg formulations in a random order i.e. 4 assessment periods. Finally there will be a down titration period. During the study and blood will be assessed and compared for pramipexole levels for at steady state at the two dose levels comparing test and reference products. There will no washout intervals between titrations or between the dose levels. 36 Male non-smoking volunteers aged between 18-55 years will take part in this study at one centre in the UK.

• REC name

  HSC REC B

• REC reference

  12/NI/0124

• Date of REC Opinion

  6 Sep 2012

• REC opinion

  Further Information Favourable Opinion