[Translation] A single-center, randomized, open-label phase I clinical study on the safety, tolerability, and pharmacokinetic characteristics of a single-dose ramosetron hydrochloride sustained-release patch in healthy subjects
主要目的:
1. 评估健康中国成年受试者单次给予盐酸雷莫司琼缓释贴片后的安全性、耐受性。
次要目的:
1. 评估健康中国成年受试者单次给予盐酸雷莫司琼缓释贴片后体内药代动力学特征。
2. 评估健康中国成年受试者单次给予盐酸雷莫司琼缓释贴片后,该贴片的粘附性。
[Translation] Primary objectives:
1. To evaluate the safety and tolerability of the ramosetron hydrochloride sustained-release patch after a single administration to healthy Chinese adult subjects.
Secondary objectives:
1. To evaluate the in vivo pharmacokinetic characteristics of the ramosetron hydrochloride sustained-release patch after a single administration to healthy Chinese adult subjects.
2. To evaluate the adhesion of the ramosetron hydrochloride sustained-release patch after a single administration to healthy Chinese adult subjects.