PK, safety & tolerability of CyCol® vs Sandimmun® in healthy subjects

• Research type

  Research Study

• Full title

  A multiple dose, multi-stage study to evaluate the safety, tolerability, pharmacokinetics and colon tissue distribution of cyclosporine capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers

• IRAS ID

  155475

• Contact name

  Muna Albayaty

• Contact email

  muna.albayaty@parexel.com

• Sponsor organisation

  Sigmoid Pharmacology

• Eudract number

  2014-001610-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  14/SC/0270

• Date of REC Opinion

  28 May 2014

• REC opinion

  Further Information Favourable Opinion