药品名称
The name of the drug | 他达拉非片
Tadalafil tablets | 受理号
Acceptance number | / |
申请分类
Application classification | □临床申请 ☑上市申请 □一致性评价申请 □补充申请第 项 □再注册申请 □复审申请
□ Clinical application ☑, Listing application□ Consistency evaluation application□ Supplementary application, □ re-registration application, □ review application |
注册分类
Register for classification | □中药 类 ☑化药4类 □治疗用生物制品 类
□ traditional Chinese medicine ☑, 4 types of chemical drugs, □ therapeutic biological products □预防用生物制品 类 □血源筛查试剂
□ biological products for prophylaxis □ blood-derived screening reagents |
剂 型
Dosage form | 片剂
Tablets | 规 格
Specifications | 20mg |
申请人
applicant | 浙江永太药业有限公司
Zhejiang Yongtai Pharmaceutical Co., Ltd |
联系人
Contact | 郑云
Zheng Yun | 联系电话
Contact number | 18248640237 |
临床试验项目信息
Clinical trial program information | 项目名称*
Project Name* | 临床试验批件号或备案号、临床试验平台登记号
The approval number or record number of the clinical trial, and the registration number of the clinical trial platform | 相关研究机构信息
Information about relevant research institutions | 原始资料保存地址
The address where the original data is saved |
| 他达拉非片（20mg）在健康男性受试者中空腹和餐后状态下的单剂量、随机、开放、两周期、两序列、双交叉设计的生物等效性试验
A Bioequivalence Trial of Tadalafil Tablets (20mg) in Fasting and Postprandial States in a Bioequivalence Trial of a Single-dose, Randomized, Open-label, Two-Cycle, Two-Sequence, Double-Crossover Design in Healthy Male Subjects | 临床试验批件号或备案号：202401454-01
Clinical trial approval number or record number: 202401454-01 临床试验平台登记号：
Clinical Trial Platform Registry Number: CTR20243108 | 临床试验机构
Clinical trial institutions 单位名称：浙江萧山医院
Company Name: Zhejiang Xiaoshan Hospital 单位地址：浙江省杭州市萧山区育才北路728号
Unit address: No. 728, Yucai North Road, Xiaoshan District, Hangzhou City, Zhejiang Province 实际研究地址：浙江省杭州市萧山区育才北路728号
Actual research address: No. 728, Yucai North Road, Xiaoshan District, Hangzhou City, Zhejiang Province GCP资格证书编号及有效期：浙江萧山医院已在药物临床试验机构备案管理信息平台进行备案，备案号：药临床机构备字2021000090
GCP qualification certificate number and expiration date: Zhejiang Xiaoshan Hospital has been filed on the record management information platform of drug clinical trial institutions, record number: pharmaceutical clinical institution preparation 2021000090 GCP资格认证地址：杭州市萧山区育才北路728号/浙江省杭州市萧山区新塘街道涝湖村山下陈17号(精神卫生中心院区）
GCP qualification certification address: No. 728, Yucai North Road, Xiaoshan District, Hangzhou City / No. 17, Shanxia Chen, Lihu Village, Xintang Street, Xiaoshan District, Hangzhou City, Zhejiang Province(Mental Health Center Campus). 研究主要负责人：陈金亮
Research Principal Investigator: Chen Jinliang 联系人及联系电话：13588482447
Contact person and contact number: 13588482447 | 浙江萧山医院/浙江省杭州市萧山区育才北路728号/13588482447
Zhejiang Xiaoshan Hospital / No. 728, Yucai North Road, Xiaoshan District, Hangzhou City, Zhejiang Province / 13588482447 |
| | | 生物样本分析实验室
Biological Sample Analysis Laboratory 单位名称：武汉宏韧生物医药股份有限公司
Company name: Wuhan Hongren Biopharmaceutical Co., Ltd 单位地址：武汉市东湖新技术开发区高新大道666号武汉国家生物产业基地B4栋
Unit address: Building B4, Wuhan National Biological Industry Base, No. 666, Gaoxin Avenue, East Lake New Technology Development Zone, Wuhan City 实际研究地址：武汉市东湖新技术开发区高新大道666号武汉国家生物产业基地B4栋
Actual research address: Building B4, Wuhan National Biological Industry Base, No. 666, Gaoxin Avenue, East Lake High-tech Development Zone, Wuhan City 研究主要负责人：蔡小影
Research Principal Investigator: Cai Xiaoying 联系人及联系电话：15872699265
Contact person and contact number: 15872699265 | 武汉宏韧生物医药股份有限公司武汉市东湖新技术开发区高新大道666号武汉国家生物产业基地B4栋/15872699265
Wuhan Hongren Biopharmaceutical Co., Ltd., Building B4/15872699265, Wuhan National Biological Industry Base, No. 666, Gaoxin Avenue, East Lake New Technology Development Zone, Wuhan City |
| | | CRO公司
CRO Inc 单位名称：杭州颐源医药技术有限公司
Company Name: Hangzhou Yiyuan Pharmaceutical Technology Co., Ltd 单位地址：浙江省杭州市钱塘区下沙街道幸福北路468号药闻科技楼7幢4楼颐源医药
Unit address: Yiyuan Pharmaceutical, 4th Floor, Building 7, Yaowen Science and Technology Building, No. 468, Xingfu North Road, Xiasha Street, Qiantang District, Hangzhou City, Zhejiang Province 研究主要负责人：蔡红丹
Research Principal Investigator: Cai Hongdan 联系人及联系电话：18867136167
Contact person and contact number: 18867136167 | 浙江省杭州市钱塘区下沙街道幸福北路468号药闻科技楼7幢4楼颐源医药/18867136167
4th Floor, Building 7, Yaowen Science and Technology Building, No. 468, Xingfu North Road, Xiasha Street, Qiantang District, Hangzhou City, Zhejiang Province, Yiyuan Pharmaceutical/18867136167 |
| | | 数据管理单位
Data Management Unit 单位名称：武汉弘质生物医药科技有限公司
Company Name: Wuhan Hongzhi Biological Pharmaceutical Technology Co., Ltd 单位地址：武汉市东湖新技术开发区高新大道666号凯瑞百谷C1栋
Unit address: Building C1, Kairui Baigu, No. 666, Gaoxin Avenue, East Lake High-tech Development Zone, Wuhan City 研究主要负责人：谭钰馨
Research Principal Investigator: Tan Yuxin 联系人及联系电话：13555928898
Contact person and contact number: 13555928898 | 武汉弘质生物医药科技有限公司
Wuhan Hongzhi Biological Pharmaceutical Technology Co., Ltd /武汉市东湖新技术开发区高新大道666号凯瑞百谷C1栋/13555928898
/ Building C1, Kairui Baigu, No. 666, Gaoxin Avenue, East Lake High-tech Development Zone, Wuhan City/13555928898 |
| | | 统计分析单位
Unit of statistical analysis 单位名称：武汉弘质生物医药科技有限公司
Company Name: Wuhan Hongzhi Biological Pharmaceutical Technology Co., Ltd 单位地址：武汉市东湖新技术开发区高新大道666号凯瑞百谷C1栋
Unit address: Building C1, Kairui Baigu, No. 666, Gaoxin Avenue, East Lake High-tech Development Zone, Wuhan City 研究主要负责人：谭楚艺
Research Principal Investigator: Tan Chuyi 联系人及联系电话：15549182951
Contact person and contact number: 15549182951 | 武汉弘质生物医药科技有限公司
Wuhan Hongzhi Biological Pharmaceutical Technology Co., Ltd /武汉市东湖新技术开发区高新大道666号凯瑞百谷C1栋/15549182951
/ Building C1, Kairui Baigu, No. 666, Gaoxin Avenue, East Lake High-tech Development Zone, Wuhan City/15549182951 |
声 明
Declarations 本报告表中填写内容和所附资料均属实，且与申报资料一致。如查有不实之处，本机构负法律责任，并承担由此造成的一切后果。
The information filled in and attached to this report form are true and consistent with the application information. If there is any inaccuracy, the institution shall bear legal responsibility and bear all the consequences arising therefrom. 申报单位负责人签名：
Signature of the person in charge of the reporting unit: (申请人公章)
(Applicant's official seal) 年 月 日
YYYYYYYYYYYYYYYYY 注：其他需要说明的情况可另附页。
Note: Other situations that need to be explained can be attached separately. |
