[Translation] Bioequivalence study of ursodeoxycholic acid tablets
评估受试制剂熊去氧胆酸片(规格:50 mg)与参比制剂熊去氧胆酸片(URSO®,规格:50 mg)在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究。
[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study was conducted to evaluate the bioequivalence of the test preparation ursodeoxycholic acid tablets (strength: 50 mg) and the reference preparation ursodeoxycholic acid tablets (URSO®, strength: 50 mg) in healthy adult subjects under fasting and fed conditions.
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