Comparative PK study of RGB-10 and Forsteo.

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Single, 20 microgram Fixed Dose, Two-Way Crossover Comparative Pharmacokinetic Study of RGB-10 and Forsteo® in Two Stages, in Healthy Adult Female Subjects.

• IRAS ID

  158379

• Contact name

  Adrian Johnston Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  Gedeon Richter Plc.

• Eudract number

  2013-004040-31

• Research summary

  The study compares the drug handling in human body, safety and tolerability of RGB-10 20 ug/80 ul and Forsteo® 20 ug/80 ul administered as subcutaneous injections.
  The proposed use for RGB-10 is the treatment of osteoporosis.
  Healthy volunteers will be dosed in a crossover manner and will provide the comparative data through blood sampling and reporting/observation of their subjective experiences and objective measures of physical parameters.
  

• REC name

  HSC REC A

• REC reference

  14/NI/1005

• Date of REC Opinion

  8 Jul 2014

• REC opinion

  Further Information Favourable Opinion