Delving into the Latest Updates on Hainan Kelaiwei Pharmaceutical Co., Ltd. with Synapse

Overview

主要研究目的：研究空腹及餐后给药条件下，海南科莱维药业有限公司委托海南赞邦制药有限公司生产的尼麦角林片（10 mg/片）与 Pfizer Italia S.r.l.持证的尼麦角林片（10 mg/片，商品名：SERMION®）在中国健康受试者体内的药代动力学，评价空腹和餐后状态下口服两种制剂的生物等效性。次要研究目的：研究海南科莱维药业有限公司委托海南赞邦制药有限公司生产的尼麦角林片（10 mg/片）与 Pfizer Italia S.r.l.持证的尼麦角林片（10 mg/片，商品名：SERMION®）在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of Nicergoline Tablets (10 mg/tablet) produced by Hainan Zanbang Pharmaceutical Co., Ltd. commissioned by Hainan Keliwei Pharmaceutical Co., Ltd. and Nicergoline Tablets (10 mg/tablet, trade name: SERMION®) certified by Pfizer Italia S.r.l. in healthy Chinese subjects under fasting and postprandial administration conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting and postprandial conditions. Secondary purpose of the study is to study the safety of Nicergoline Tablets (10 mg/tablet) produced by Hainan Zanbang Pharmaceutical Co., Ltd. commissioned by Hainan Keliwei Pharmaceutical Co., Ltd. and Nicergoline Tablets (10 mg/tablet, trade name: SERMION®) certified by Pfizer Italia S.r.l. in healthy Chinese subjects.

Start Date08 Aug 2022

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Hainan Kelaiwei Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hainan Kelaiwei Pharmaceutical Co., Ltd.

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