Delving into the Latest Updates on Kunshan Rotam Reddy Pharmaceutical Co. Ltd. with Synapse

Overview

Tags

Nervous System Diseases

Cardiovascular Diseases

Other Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

ADRA1(Adrenergic receptor alpha-1)	1

中国健康成年受试者在空腹状态下单次口服盐酸埃克替尼片（125mg）受试制剂（昆山龙灯瑞迪制药有限公司生产）和盐酸埃克替尼片（125mg）参比制剂（凯美纳®，贝达药业股份有限公司持证生产）的随机、开放、两制剂、两序列、四周期，完全重复交叉设计的生物等效性试验

[Translation] A randomized, open-label, two-dose, two-sequence, four-period, fully replicated crossover bioequivalence study of a single oral dose of icotinib hydrochloride tablets (125 mg) (produced by Kunshan Longdeng Redi Pharmaceutical Co., Ltd.) and a reference formulation of icotinib hydrochloride tablets (125 mg) (Conmana®, licensed production by Betta Pharmaceuticals Co., Ltd.) in healthy Chinese adult subjects in the fasting state

主要研究目的：研究空腹状态下单次口服盐酸埃克替尼片（125mg）受试制剂（昆山龙灯瑞迪制药有限公司生产）和盐酸埃克替尼片（125mg）参比制剂（凯美纳®，贝达药业股份有限公司持证生产）在健康成年受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。次要研究目的：评价健康受试者在空腹状态下，单次口服盐酸埃克替尼片（125mg）受试制剂和参比制剂后的安全性。

[Translation]

Primary study objective: To study the pharmacokinetics of a single oral dose of icotinib hydrochloride tablets (125 mg) (produced by Kunshan Longdeng Redi Pharmaceutical Co., Ltd.) and a reference formulation of icotinib hydrochloride tablets (125 mg) (Conmana®, licensed production by Beda Pharmaceutical Co., Ltd.) in healthy adult subjects in the fasting state, and to evaluate the bioequivalence of the two formulations in the fasting state. Secondary study objective: To evaluate the safety of a single oral dose of icotinib hydrochloride tablets (125 mg) and a reference formulation in healthy subjects in the fasting state.

Start Date20 Jul 2024

Sponsor / Collaborator

Kunshan Rotam Reddy Pharmaceutical Co. Ltd.

CTR20241832 / CompletedNot Applicable

中国健康成年受试者在餐后状态下单次口服盐酸埃克替尼片（125mg）受试制剂（昆山龙灯瑞迪制药有限公司生产）和盐酸埃克替尼片（125mg）参比制剂（凯美纳®，贝达药业股份有限公司持证生产）的随机、开放、两制剂、两序列、两周期，双交叉设计的生物等效性试验

[Translation] A randomized, open-label, two-dose, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of icotinib hydrochloride tablets (125 mg) (produced by Kunshan Longdeng Redi Pharmaceutical Co., Ltd.) and a reference formulation of icotinib hydrochloride tablets (125 mg) (Conmana®, licensed production by Betta Pharmaceuticals Co., Ltd.) in healthy Chinese adult subjects in the fed state

主要研究目的：研究餐后状态下单次口服盐酸埃克替尼片（125mg）受试制剂（昆山龙灯瑞迪制药有限公司生产）和盐酸埃克替尼片（125mg）参比制剂（凯美纳®，贝达药业股份有限公司持证生产）在健康成年受试者体内的药代动力学，评价餐后状态口服两种制剂的生物等效性。次要研究目的：评价健康受试者在餐后状态下，单次口服盐酸埃克替尼片（125mg）受试制剂和参比制剂后的安全性。

[Translation]

Primary study objective: To study the pharmacokinetics of a single oral dose of icotinib hydrochloride tablets (125 mg) (produced by Kunshan Longdeng Redi Pharmaceutical Co., Ltd.) and a reference formulation of icotinib hydrochloride tablets (125 mg) (Conmana®, licensed production by Beda Pharmaceutical Co., Ltd.) in healthy adult subjects, and to evaluate the bioequivalence of the two formulations in the fed state. Secondary study objective: To evaluate the safety of a single oral dose of icotinib hydrochloride tablets (125 mg) and a reference formulation in healthy subjects in the fed state.

Start Date12 Jun 2024

Sponsor / Collaborator

Kunshan Rotam Reddy Pharmaceutical Co. Ltd.

CTR20241289 / CompletedNot Applicable

中国健康成年受试者在空腹/餐后状态下单次口服布瑞哌唑片（2 mg）受试制剂和参比制剂（Rexulti®）的生物等效性试验

[Translation] Bioequivalence study of a single oral dose of brexpiprazole tablets (2 mg) in healthy Chinese adult subjects in the fasting/fed state and compared with the reference product (Rexulti®)

主要研究目的：本研究以昆山龙灯瑞迪制药有限公司研制的布瑞哌唑片（规格：2 mg）为受试制剂，按生物等效性研究的有关规定，以Otsuka Pharmaceutical Co., Ltd.持证并生产的布瑞哌唑片（规格：2 mg，商品名：Rexulti®）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要研究目的：观察受试制剂布瑞哌唑片和参比制剂布瑞哌唑片（Rexulti®）在健康受试者中的安全性。

[Translation]

Main research purpose: This study uses brepirazole tablets (specification: 2 mg) developed by Kunshan Longdeng Ruidi Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, brepirazole tablets (specification: 2 mg, trade name: Rexulti®) certified and produced by Otsuka Pharmaceutical Co., Ltd. are used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary research purpose: Observe the safety of the test preparation brepirazole tablets and the reference preparation brepirazole tablets (Rexulti®) in healthy subjects.

Start Date08 May 2024

Sponsor / Collaborator

Kunshan Rotam Reddy Pharmaceutical Co. Ltd.

100 Clinical Results associated with Kunshan Rotam Reddy Pharmaceutical Co. Ltd.

Login to view more data

0 Patents (Medical) associated with Kunshan Rotam Reddy Pharmaceutical Co. Ltd.

Login to view more data

100 Deals associated with Kunshan Rotam Reddy Pharmaceutical Co. Ltd.

Login to view more data

100 Translational Medicine associated with Kunshan Rotam Reddy Pharmaceutical Co. Ltd.

Login to view more data

Corporation Tree

Boost your research with our corporation tree data.

login

or

view full example data

Boost your research with our corporation tree data.

Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 1 Clinical

1

Login to view more data