PHARMACOKINETICS OF BIOEQUIVALENT DOSES OF FLUORIDES

氟化物生物当量剂量的药代动力学

• 批准号: 6567660
• 负责人: KHASHAYAR SAKHAEE
• 金额: $ 32.14万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6567660
• 关键词: clinical research; dosage; gastrointestinal nutrient absorption; human subject; ingested fluoride therapy; nutrient bioavailability; pharmacokinetics

The objective of this protocol is to perform a single dose bioavailability study of Neosten 25 mg, and compare it with that of plain sodium fluoride 10 mg. It will test the hypothesis that at the same bioequivalent dose, plain NaF would be more rapidly absorbed and would cause a higher serum fluoride peak, than Neosten. Thus, it is expected that plain NaF 10 mg, compared to Neosten 25 mg, would yield a higher peak with fluoride concentration, shorter time to reach peak and half time of decline, but an equivalent change in area under the curve.

本方案旨在进行单次给药 Neosten 25 mg的生物利用度研究，并与 普通氟化钠10 mg。 它 将检验假设， 相同的生物等效剂量，普通氟化钠会更快地吸收， 会导致比Neosten更高的血清氟峰值。 照经上所 预计纯氟化钠10毫克，相比Neosten 25毫克，将产生 氟离子浓度越高，达到峰值的时间越短 和下降的一半时间，但在面积的变化下， 曲线