A deflazacort relative bioavailability study in healthy participants

• Research type

  Research Study

• Full title

  A Single-Dose, Single-Center, Randomized, Two Period Crossover Study Comparing the Relative Bioavailability of Delazacort Tablets to Calcort® Tablets in Healthy Volunteers

• IRAS ID

  191589

• Contact name

  Adrian/J Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  Marathon Pharmaceuticals, LLC

• Eudract number

  2015-004009-18

• Duration of Study in the UK

  0 years, 1 months, 10 days

• Research summary

  The purpose of this study is to compare a new oral formulation of deflazacort with the currently marketed Calcort®) formulation of delazacort 36 mg (6 x 6 mg) tablets in healthy volunteer participants. The Clinical Trial will be conducted at one centre within the UK, and will involve 42 male and female participants.

• REC name

  HSC REC A

• REC reference

  15/NI/0213

• Date of REC Opinion

  4 Nov 2015

• REC opinion

  Further Information Favourable Opinion