[Translation] A single-center, open-label, randomized, single-dose, two-period, four-sequence, crossover bioequivalence and adhesion study to evaluate the bioequivalence of the test product, rotigotine patch (strength: 4.5 mg/10 cm2 (release 2 mg/24 h)) and the reference product, rotigotine patch (Upro®, strength: 2 mg/24 h), in healthy adult subjects under topical conditions
主要试验目的:
研究外用条件下单次给予受试制剂罗替高汀贴片(规格:4.5 mg/10 cm2(释药量2 mg/24 h))与参比制剂罗替高汀贴片(优普洛®,规格:2 mg/24 h)在健康受试者体内的药代动力学特征和黏附力,为正式人体生物等效性和黏附力研究提供参考。
次要试验目的:
研究受试制剂罗替高汀贴片(规格:4.5 mg/10 cm2(释药量2 mg/24 h))和参比制剂罗替高汀贴片(优普洛®)(规格:2 mg/24 h)在健康受试者中的安全性。
[Translation] Main purpose of the study:
To study the pharmacokinetic characteristics and adhesion of the test preparation Rotigotine patch (specification: 4.5 mg/10 cm2 (drug release 2 mg/24 h)) and the reference preparation Rotigotine patch (Upro®, specification: 2 mg/24 h) in healthy subjects after single administration under topical conditions, and to provide a reference for formal human bioequivalence and adhesion studies.
Secondary purpose of the study:
To study the safety of the test preparation Rotigotine patch (specification: 4.5 mg/10 cm2 (drug release 2 mg/24 h)) and the reference preparation Rotigotine patch (Upro®) (specification: 2 mg/24 h) in healthy subjects.