Comparison of bioavailability & PD profile of Zegerid & Losec

• Research type

  Research Study

• Full title

  A Randomised, Three-Period, Single Dose, Open-Label, Crossover Study to Investigate the Relative Bioavailability and Pharmacodynamic Profile of a Zegerid® 20mg Capsule, Zegerid® 20mg Powder for Oral Suspension and Losec® 20mg Capsule in Healthy Adult volunteers under Fasting Conditions.

• IRAS ID

  48422

• Contact name

  Thomas Jerome Hanna

• Sponsor organisation

  Norgine Ltd

• Eudract number

  2010-022564-13

• Research summary

  A study to determine the rate of absorption, effects and concentration levels in the blood of a drug used for the treatment of heartburn & indigestion and the effects of the drug on the body (in particular the concentration of acid in the stomach) compared to Losec, a marketed product.

• REC name

  HSC REC B

• REC reference

  10/NIR03/50

• Date of REC Opinion

  30 Sep 2010

• REC opinion

  Further Information Favourable Opinion