/ Not yet recruitingNot Applicable [Translation] Bioequivalence Study of Ursodeoxycholic Acid Capsules
主要目的:在餐后状态下,以 ABC FARMACEUTICI S.p.A.生产的熊去氧胆酸胶囊(规格:250 mg)为受试制剂,以持证商为 Dr. Falk Pharma GmbH 的熊去氧胆酸胶囊(商品名:优思弗,规格:250 mg)为参比制剂,比较两制剂在中国健康受试者体内吸收程度和速度的差异。通过主要药代动力学参数及相对生物利用度,评价两种制剂是否具有生物等效性。
次要目的:观察熊去氧胆酸胶囊受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: In the postprandial state, ursodeoxycholic acid capsules (specification: 250 mg) produced by ABC FARMACEUTICI S.p.A. were used as the test preparation, and ursodeoxycholic acid capsules (trade name: Ursof, specification: 250 mg) produced by Dr. Falk Pharma GmbH were used as the reference preparation to compare the differences in the absorption extent and speed of the two preparations in healthy Chinese subjects. The main pharmacokinetic parameters and relative bioavailability were used to evaluate whether the two preparations were bioequivalent.
Secondary objective: To observe the safety of the test preparation and reference preparation of ursodeoxycholic acid capsules in healthy subjects.
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