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pmid: 28744102
pmc: PMC5513855
The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product FosamaxA 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) methods.The average maximum concentrations (The generic product was bioequivalent to the reference product in terms of the rate and extent of alendronate absorption after a single 70 mg oral dose under fasting conditions.
Adult, Male, Cross-Over Studies, Adolescent, Alendronate, Bone Density Conservation Agents, Biological Availability, Healthy Volunteers, Young Adult, alendronate sodium, Asian People, Therapeutic Equivalency, Area Under Curve, Drugs, Generic, Humans, reference-scaled average bioequivalence, pharmacokinetics, highly variable drug, Original Research
Adult, Male, Cross-Over Studies, Adolescent, Alendronate, Bone Density Conservation Agents, Biological Availability, Healthy Volunteers, Young Adult, alendronate sodium, Asian People, Therapeutic Equivalency, Area Under Curve, Drugs, Generic, Humans, reference-scaled average bioequivalence, pharmacokinetics, highly variable drug, Original Research
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citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | 8 | |
popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network. | Top 10% | |
influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Average | |
impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Average |