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

Autor:	Denker, Andrew E., Lazarus, Nicole, Porras, Arturo, Ramakrishnan, Rohini, Constanzer, Marvin, Scott, Boyd B., Chavez-Eng, Cynthia, Woolf, Eric, Maganti, Lata, Larson, Patrick, Gottesdiener, Keith, Wagner, John A.
Předmět:	ANALYSIS of variance BIOAVAILABILITY BIOLOGICAL assay COMBINATION drug therapy CONFIDENCE intervals CROSSOVER trials DIPHOSPHONATES BONE fractures HIGH performance liquid chromatography MASS spectrometry MEDICAL cooperation OSTEOPOROSIS HEALTH outcome assessment RESEARCH RESEARCH funding STATISTICAL sampling URINALYSIS CHOLECALCIFEROL TREATMENT effectiveness
Zdroj:	Journal of Clinical Pharmacology; Oct2011, Vol. 51 Issue 10, p1439-1448, 10p
Abstrakt:	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. [ABSTRACT FROM PUBLISHER]
Databáze:	Complementary Index
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