Effervescent formulation vs. Risenex-plus in healthy volunteers

• Research type

  Research Study

• Full title

  A two arm, open-label, randomised two-way crossover study in healthy volunteers to investigate the gastric emptying and gastric pH of a new effervescent product containing risedronate versus Risenex-plus using scintigraphic methods

• IRAS ID

  214824

• Contact name

  Laura Brotherton

• Contact email

  laura.brotherton@bddpharma.com

• Sponsor organisation

  Bio-Images Research Ltd

• Eudract number

  2016-003595-50

• Duration of Study in the UK

  0 years, 1 months, 5 days

• Research summary

  This study will investigate a new effervescent tablet formulation called GLE1RCW against a commercially marketed comparator called Risenex-plus tablets, both of which contain risedronate sodium and Vitamin D as the active ingredients. GLE1RCW and Risenex-plus are intended to treat patients with post-menopausal osteoporosis.

  Up to 12 healthy female volunteers will be recruited, and each will receive the following treatments throughout the study:

  Treatment A: GLE1RCW effervescent tablet containing 35 mg risedronate sodium and 5600 IU Vitamin D3
  Treatment B: Risenex-plus tablet containing 35 mg risedronate sodium and 5600 IU Vitamin D3

  We will be looking at:
  - The gastric emptying time of the GLE1RCW and Risenex-plus tablets (when they leave the stomach)
  - The stomach pH after receiving each formulation (the acid levels of the stomach)
  - The behaviour of the Risenex-plus tablet (when, where and how quickly it breaks up)

  To look at these parameters we will add a small amount of radioactive material to the Risenex-plus tablets and to the water given with the GLE1RCW effervescent tablet.

• REC name

  Scotland A: Adults with Incapacity only

• REC reference

  16/SS/0170

• Date of REC Opinion

  3 Feb 2017

• REC opinion

  Further Information Unfavourable Opinion