Bioequivalence study for strontium pharmacokinetic parameters

• Research type

  Research Study

• Full title

  Bioequivalence study for strontium pharmacokinetic parameters after a single oral administration of strontium succinate 1.2 g administered as a dispersed tablet versus a sachet of strontium ranelate 2g, in healthy young male volunteers. Open label, 2-period, 2-cross over, 2-sequence, monocentric study.

• IRAS ID

  88178

• Contact name

  Simon Singer

• Sponsor organisation

  Institut de Recherches Internationales Servier

• Eudract number

  2011-002421-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Strontium, as sachets of strontium ranelate has been marketed in Europe since 2004, for the treatment of osteoporosis (thinning of the bones), in postmenopausal women, to reduce the risk of fractures. Although proven to be effective, strontium is poorly absorbed when given as strontium ranelate; a previous study has shown that formulating it as strontium succinate improves absorption; the succinate part does not have an effect. In the previous study, strontium succinate was given to healthy male volunteers in doses of 400, 800 and 1600 mg. It was found that the amount of strontium detectable in the blood after a 2 g strontium ranelate sachet was roughly halfway between the amount after an 800 mg strontium succinate tablet and a 1600 mg strontium succinate tablet were given. This suggests that a dose of 1200 mg is likely to be equivalent to 2 g strontium ranelate.It is not intended that volunteers will receive any therapeutic benefit from taking part in the study.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/SC/0442

• Date of REC Opinion

  21 Oct 2011

• REC opinion

  Favourable Opinion