Pharmacokinetics and tolerability of minodronic acid tablets in healthy Chinese subjects and food and age effects on the pharmacokinetics

Clinical Therapeutics
Ying ZhouWeiyong Li

Abstract

Minodronic acid is a third-generation bisphosphonate being developed for the treatment of osteoporosis. The aim of this study was to evaluate the pharmacokinetic profiles and tolerability of minodronic acid in healthy subjects, as well as to assess the effects of food and age on the pharmacokinetics. This single-center, open-label, Phase I study was conducted in 4 parts. In part 1, minodronic acid tablets were administered to young volunteers at doses of 1, 2, and 4 mg. In part 2, after a single dose, young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days. In part 3, a single oral dose of minodronic acid 1 mg was administered to elderly volunteers. In part 4, after a washout period of 8 days, volunteers in the 4-mg group received a single dose of 4-mg minodronic acid under fed conditions (administrated 30 minutes before a high-fat breakfast). Plasma samples were collected, and plasma concentrations of minodronic acid were analyzed by using a LC-MS/MS method. Tolerability was assessed throughout the study by physical examinations, measurement of vital signs, laboratory analyses, and monitoring of adverse events. Thirty-six young volunteers (mean age, 22.1 years; mean weight,...Continue Reading

References

Dec 3, 2005·The Journal of Clinical Investigation·Lawrence G Raisz
Dec 23, 2008·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·T MatsumotoT Nakamura
Sep 15, 2009·Nihon yakurigaku zasshi. Folia pharmacologica Japonica·Makoto TanakaKeiji Miyata
Mar 5, 2010·Drugs of Today·Tadahiko KuboMitsuo Ochi
Mar 26, 2010·The New England Journal of Medicine·Dennis M BlackUNKNOWN HORIZON Pivotal Fracture Trial Steering Committee
Jan 11, 2014·Drug Delivery·Mohammad FazilJaved Ali

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