[Translation] A multicenter, randomized, double-blind, positive drug parallel controlled, equivalent clinical trial of nifuratel nystatin vaginal soft capsules for simple vulvovaginal candidiasis

主要目的：以硝呋太尔制霉菌素阴道软胶囊（商品名：麦咪康帕®）为阳性对照，评估江苏万高药业生产的试验药物硝呋太尔制霉菌素阴道软胶囊用于单纯性外阴阴道假丝酵母菌病的有效性，评估两制剂是否为等效制剂。？次要目的：以硝呋太尔制霉菌素阴道软胶囊（商品名：麦咪康帕®）为阳性对照，评估试验药物硝呋太尔制霉菌素阴道软胶囊用于单纯性外阴阴道假丝酵母菌病的安全性。

[Translation]

Main purpose: Using nifuratel nystatin vaginal soft capsules (trade name: Maimikangpa®) as a positive control, evaluate the effectiveness of the experimental drug nifuratel nystatin vaginal soft capsules produced by Jiangsu Wangao Pharmaceutical for simple vulvovaginal candidiasis, and evaluate whether the two preparations are equivalent preparations. ? Secondary purpose: Using nifuratel nystatin vaginal soft capsules (trade name: Maimikangpa®) as a positive control, evaluate the safety of the experimental drug nifuratel nystatin vaginal soft capsules for simple vulvovaginal candidiasis.

Start Date04 Sep 2024

Sponsor / Collaborator

Jiangsu Vanguard Pharmaceutical Co.,Ltd.

CTR20232737

/ RecruitingPhase 3

硝呋太尔制霉菌素阴道软胶囊治疗细菌性阴道病的随机、双盲、平行对照、多中心临床研究

[Translation] A randomized, double-blind, parallel-controlled, multicenter clinical study of nifuratel and nystatin vaginal soft capsules in the treatment of bacterial vaginosis

主要研究目的：比较烟台鲁银药业有限公司生产的试验药物硝呋太尔制霉菌素阴道软胶囊与 POLICHEM S.R.L 持证的对照药品硝呋太尔制霉菌素阴道软胶囊(商品名：麦咪康帕)治疗细菌性阴道病的临床疗效一致性。次要研究目的：评价试验药物硝呋太尔制霉菌素阴道软胶囊和对照药品硝呋太尔制霉菌素阴道软胶囊(商品名：麦咪康帕)的安全性。

[Translation]

The main purpose of the study is to compare the clinical efficacy consistency of the experimental drug nifuratel nystatin vaginal soft capsule produced by Yantai Luyin Pharmaceutical Co., Ltd. and the control drug nifuratel nystatin vaginal soft capsule (trade name: Maimikangpa) certified by POLICHEM S.R.L. in the treatment of bacterial vaginosis. Secondary purpose of the study is to evaluate the safety of the experimental drug nifuratel nystatin vaginal soft capsule and the control drug nifuratel nystatin vaginal soft capsule (trade name: Maimikangpa).

Start Date15 May 2024

Sponsor / Collaborator

Yantai Luyin Pharmaceutical Co. Ltd.

CTR20232169

/ CompletedPhase 3

硝呋太尔制霉菌素阴道软胶囊治疗单纯滴虫性、细菌性、外阴阴道念珠菌性及混合性感染阴道病的多中心、随机、双盲、阳性药物平行对照临床试验

[Translation] A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial of nifuratel nystatin vaginal soft capsules in the treatment of simple trichomonas, bacterial, vulvovaginal candidiasis and mixed infections of vaginosis

评价江苏征瑞医药科技有限公司生产的硝呋太尔制霉菌素阴道软胶囊（规格：每粒含硝呋太尔0.5g和制霉菌素200,000单位）与普利化学工业公司、意大利多帕药业有限公司生产的对照药品硝呋太尔制霉菌素阴道软胶囊麦咪康帕®（规格：每粒含硝呋太尔0.5g和制霉菌素200,000单位）的有效性是否有差异，评价两制剂是否为等效性制剂。

[Translation]

To evaluate whether there is any difference in effectiveness between the nifuratel-nystatin vaginal soft capsules (specification: each capsule contains 0.5 g nifuratel and 200,000 units of nystatin) produced by Jiangsu Zhengrui Pharmaceutical Technology Co., Ltd. and the control drug nifuratel-nystatin vaginal soft capsules Mamicompa® (specification: each capsule contains 0.5 g nifuratel and 200,000 units of nystatin) produced by Pulli Chemical Industry Company and Dopa Pharmaceutical Co., Ltd. of Italy, and to evaluate whether the two preparations are equivalent preparations.

Start Date11 Sep 2023

Sponsor / Collaborator

Jiangsu Zhengrui Medical Technology Co., Ltd.

100 Clinical Results associated with Nifuratel/Nystatin

100 Translational Medicine associated with Nifuratel/Nystatin

100 Patents (Medical) associated with Nifuratel/Nystatin

100 Deals associated with Nifuratel/Nystatin

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Candidiasis, Vulvovaginal	China	Polichem Srl	01 Jan 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

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