[Translation] A single-center, randomized, open-label, two-dose, four-period, single-dose, completely repeated crossover bioequivalence study of vardenafil hydrochloride tablets in Chinese healthy subjects in the postprandial state

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在餐后状态下口服受试制剂盐酸伐地那非片（规格：20mg，持证商：杭州民生药物研究院有限公司）与参比制剂盐酸伐地那非片（规格：20mg，持证商：Bayer AG，商品名：Levitra®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂盐酸伐地那非片和参比制剂盐酸伐地那非片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation vardenafil hydrochloride tablets (specification: 20 mg, licensee: Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.) and the reference preparation vardenafil hydrochloride tablets (specification: 20 mg, licensee: Bayer AG, trade name: Levitra®) in healthy subjects after oral administration in the postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation vardenafil hydrochloride tablets and the reference preparation vardenafil hydrochloride tablets in healthy subjects.

Start Date-

Sponsor / Collaborator

Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

CTR20244010

/ RecruitingNot Applicable

盐酸伐地那非片在中国健康受试者空腹和餐后状态下的单中心、随机、开放、两制剂、四周期、两序列、单次给药、完全重复交叉生物等效性研究

[Translation] A single-center, randomized, open-label, two-dose, four-period, two-sequence, single-dose, completely repeated crossover bioequivalence study of vardenafil hydrochloride tablets in Chinese healthy subjects under fasting and fed conditions

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂盐酸伐地那非片（规格：20mg，持证商：杭州民生药物研究院有限公司）与参比制剂盐酸伐地那非片（规格：20mg，持证商：Bayer AG，商品名：Levitra®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂盐酸伐地那非片和参比制剂盐酸伐地那非片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation vardenafil hydrochloride tablets (specification: 20 mg, licensee: Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.) and the reference preparation vardenafil hydrochloride tablets (specification: 20 mg, licensee: Bayer AG, trade name: Levitra®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation vardenafil hydrochloride tablets and the reference preparation vardenafil hydrochloride tablets in healthy subjects.

Start Date09 Oct 2024

Sponsor / Collaborator

Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

CTR20234025

/ CompletedNot Applicable

盐酸伐地那非片在中国健康受试者空腹和餐后状态下的单中心、随机、开放、两制剂、四周期、两序列、单次给药、完全重复交叉生物等效性研究

主要目的：以伐地那非的主要药代动力学参数（AUC和Cmax）为生物等效性评价指标，在中国健康受试者空腹和餐后状态下评估受试制剂（杭州民生药物研究院有限公司委托江苏万高药业股份有限公司生产的盐酸伐地那非片，规格：20mg）和参比制剂（Bayer AG持证的盐酸伐地那非片，规格：20mg；商品名：Levitra®）的生物等效性。次要目的：观察空腹和餐后状态下受试制剂和参比制剂的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation (vardenafil hydrochloride tablets, specification: 20 mg, produced by Jiangsu Wangao Pharmaceutical Co., Ltd., commissioned by Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.) and the reference preparation (vardenafil hydrochloride tablets certified by Bayer AG, specification: 20 mg; trade name: Levitra®) in Chinese healthy subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of vardenafil as bioequivalence evaluation indicators. Secondary objective: To observe the safety of the test preparation and the reference preparation under fasting and fed conditions.

Start Date08 Dec 2023

Sponsor / Collaborator

Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

100 Clinical Results associated with Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

0 Patents (Medical) associated with Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

100 Deals associated with Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

100 Translational Medicine associated with Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 25 Jan 2025

No data posted

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

Overview

Related

Corporation Tree

Pipeline

Pipeline Snapshot as of 25 Jan 2025

Deal

Translational Medicine

Profit

Grant & Funding(NIH)

Investment

Financing