Bioavailability and biological efficacy of a new oral formulation of salmon calcitonin in healthy volunteers

Détails

ID Serval
serval:BIB_C57FB378903F
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Bioavailability and biological efficacy of a new oral formulation of salmon calcitonin in healthy volunteers
Périodique
Journal of Bone and Mineral Research
Auteur(s)
Buclin  T., Cosma Rochat  M., Burckhardt  P., Azria  M., Attinger  M.
ISSN
0884-0431 (Print)
Statut éditorial
Publié
Date de publication
08/2002
Volume
17
Numéro
8
Pages
1478-85
Notes
Clinical Trial
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't --- Old month value: Aug
Résumé
Salmon calcitonin (SCT) is a well-tolerated peptide drug with a wide therapeutic margin and is administered parenterally for long-term treatments of bone diseases. Its clinical usefulness would be enhanced by the development of an orally active formulation. In this randomized crossover double-blinded phase I trial, controlled by both a placebo and a parenteral verum, we have tested a new oral formulation of SCT associated with a caprylic acid derivative as carrier. Eight healthy volunteers received single doses of 400, 800, and 1200 microg of SCT orally, a placebo, and a 10-microg (50 IU) SCT intravenous infusion. SCT was reliably absorbed from the oral formulation, with an absolute bioavailability of 0.5-1.4%, depending on the dose. It induced a marked, dose-dependent drop in blood and urine C-terminal telopeptide of type I collagen (CTX), a sensitive and specific bone resorption marker, with the effects of 1200 microg exceeding those of 10 microg intravenously. It also decreased blood calcium and phosphate, and increased the circulating levels of parathyroid hormone (PTH) and, transiently, the urinary excretion of calcium. It was well-tolerated, with some subjects presenting mild and transient nausea, abdominal cramps, diarrheic stools, and headaches. This study shows that oral delivery of SCT is feasible with reproducible absorption and systemic biological efficacy. Such an oral formulation could facilitate the use of SCT in the treatment of osteoporosis and other bone diseases.
Mots-clé
Adult Biological Availability Calcitonin/adverse effects/*pharmacokinetics/*therapeutic use Calcium/blood/urine Cross-Over Studies Double-Blind Method Half-Life Humans Male
Pubmed
Web of science
Création de la notice
21/01/2008 12:14
Dernière modification de la notice
03/03/2018 21:15
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