Bioequivalence of generic alendronate sodium tablets (70 mg) to Fosamax^® tablets (70 mg) in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study.

ABSTRACT:

Purpose

The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax^® 70 mg tablet.

Materials and methods

A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg). Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) reference-scaled average bioequivalence (RSABE

SUBMITTER: Zhang Y 

PROVIDER: S-EPMC5513855 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature