Study of the bioavailability of cinacalcet capsules compared to the approved cinacalcet tablets

Update Il y a 4 ans
Reference: EUCTR2014-005034-66

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

The primary objective of this study is to evaluate the comparative bioavailability based on AUC0-inf, AUC0-t, and Cmax, between six of the 5 mg capsules of cinacalcet swallowed whole with applesauce, contents of six of the 5 mg capsules sprinkled over applesauce, and a single 30 mg commercial formulation tablet of cinacalcet with applesauce in healthy adult volunteers under fasted conditions.


Inclusion criteria

  • Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma

Links