[Translation] A single-center, open-label, randomized, single-dose, two-period, crossover bioequivalence study to evaluate the efficacy of the test product, canagliflozin tablets 100 mg, and the reference product "INVOKANA®" 100 mg in healthy adult subjects in the fasting and fed state
主要研究目的:研究健康成年受试者空腹和餐后口服受试制剂卡格列净片100 mg与参比制剂“INVOKANA®”100 mg的药代动力学,评价空腹和餐后口服卡格列净片受试制剂和参比制剂的生物等效性。
次要研究目的:研究受试制剂卡格列净片100 mg与参比制剂“INVOKANA®”100 mg在健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation canagliflozin tablets 100 mg and the reference preparation "INVOKANA®" 100 mg in healthy adult subjects after fasting and after meals, and to evaluate the bioequivalence of the test preparation and the reference preparation of canagliflozin tablets after fasting and after meals.
Secondary purpose of the study is to study the safety of the test preparation canagliflozin tablets 100 mg and the reference preparation "INVOKANA®" 100 mg in healthy adult subjects.