PK of Pyridostigmine Bromide to assess bioequivalence (QBR111880)

• Research type

  Research Study

• Full title

  A 2-Part Study to Investigate the Pharmacokinetics of Pyridostigmine Bromide Administered as 2 New Solution Formulations and to Assess Bioequivalence with the Current Marketed 60 mg Oral Tablet Product

• IRAS ID

  109195

• Contact name

  Stuart J Mair

• Sponsor organisation

  Adeptio Pharmaceuticals Ltd

• Eudract number

  2012-002497-31

• Research summary

  The Sponsor is developing a pyridostigmine bromide oral solution, for the potential treatment of myasthenia gravis. Myasthenia gravis is an autoimmune neuromuscular disease, which causes muscle weakening and fatigue. Pyridostigmine bromide is currently marketed as an immediate release tablet under the name Mestinon, for the treatment of this indication. However, due to the muscle weakness caused by the disease, swallowing these tablets can be difficult for some sufferers. Therefore, the Sponsor is developing a new easy to swallow pyridostigmine bromide oral solution, intended to be bioequivalent to the immediate release tablets. The study will aim to identify the pharmacokinetics (PK) of the study formulations (to assess how well pyridostigmine is absorbed into the bloodstream) and compare their bioavailability to Mestinon tablets. In this study, healthy male and female subjects will receive over 2 study parts either the test IMPs, pyridostigmine bromide as 2 different prototype 60mg/5mL solutions (including or excluding sorbitol), or the comparator Mestinon, a 60mg oral immediate release tablet. In Part 1, the PK profile of pyridostigmine bromide will be characterised and compared with that of Mestinon. In Part 2, its bioequivalence will be assessed.

• REC name

  Scotland A REC

• REC reference

  12/SS/0105

• Date of REC Opinion

  18 Jul 2012

• REC opinion

  Further Information Favourable Opinion