Bioavailability of Alendronate and Vitamin D3 in an Alendronate/Vitamin D3 Combination Tablet

These studies were designed to demonstrate that the alendronate (ALN) component of an ALN/vitamin D3 combination tablet was bioequivalent to the 70‐mg ALN tablet and that the pharmacokinetic parameters of vitamin D3 were similar with or without ALN. These were open‐label, randomized, 2‐part, 2‐perio...

Full description

Saved in:
Bibliographic Details
Published in:Journal of clinical pharmacology 2011-10, Vol.51 (10), p.1439-1448
Main Authors: Denker, Andrew E., Lazarus, Nicole, Porras, Arturo, Ramakrishnan, Rohini, Constanzer, Marvin, Scott, Boyd R., Chavez-Eng, Cynthia, Woolf, Eric, Maganti, Lata, Larson, Patrick, Gottesdiener, Keith, Wagner, John A.
Format: Article
Language:English
Subjects:
Alendronate
Bioavailability
bioequivalence
vitamin D
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:These studies were designed to demonstrate that the alendronate (ALN) component of an ALN/vitamin D3 combination tablet was bioequivalent to the 70‐mg ALN tablet and that the pharmacokinetic parameters of vitamin D3 were similar with or without ALN. These were open‐label, randomized, 2‐part, 2‐period, crossover studies. In part I, participants received either a single combination tablet or ALN 70 mg. In part II, participants received either a single combination tablet or vitamin D3 alone. Results from part I showed that the geometric mean ratio (GMR) for total urinary excretion of ALN for both studies fell within the prespecified bioequivalence bounds. Results from part II showed that the pharmacokinetic profiles of vitamin D3 with or without ALN were also similar. The combination tablets are bioequivalent to the ALN 70‐mg tablet with respect to ALN bioavailability. The bioavailability of vitamin D3 is similar in the combination tablets and when administered alone. No serious adverse experiences were reported.
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270010382010