Delving into the Latest Updates on Shandong Ruzhi Biomedical Technology Co., Ltd. with Synapse

Overview

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Cardiovascular Diseases

Respiratory Diseases

Other Diseases

Small molecule drug

Disease domain score

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Technology Platform

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Disease Domain	Count

Nervous System Diseases	2
Neoplasms	1
Immune System Diseases	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	3

主要目的：研究空腹和餐后状态下健康志愿者口服受试制剂乙酰半胱氨酸口服溶液与参比制剂乙酰半胱氨酸颗粒（商品名：富露施®）的体内药代动力学特征，评价空腹和餐后状态给药时两种制剂的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To study the in vivo pharmacokinetic characteristics of the test preparation acetylcysteine oral solution and the reference preparation acetylcysteine granules (trade name: Fluoxetine®) in healthy volunteers in the fasting and fed state, and to evaluate the bioequivalence of the two preparations when administered in the fasting and fed state. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date-

Sponsor / Collaborator

Shandong Ruzhi Biomedical Technology Co., Ltd.

CTR20244186

/ Not yet recruitingNot Applicable

坎地氢噻片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of candecahydrotia tablets in healthy subjects under fasting and fed conditions

主要目的：比较空腹和餐后给药条件下，山东如至生物医药科技有限公司提供的坎地氢噻片（每片含坎地沙坦酯16mg、氢氯噻嗪12.5mg）与CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片（每片含坎地沙坦酯16mg、氢氯噻嗪12.5mg，商品名：Blopress®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的：评价空腹和餐后给药条件下，山东如至生物医药科技有限公司提供的坎地氢噻片（每片含坎地沙坦酯16mg、氢氯噻嗪12.5mg）与CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片（每片含坎地沙坦酯16mg、氢氯噻嗪12.5mg，商品名：Blopress®）在健康成年人群中的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of candesartan cilexetil tablets (containing 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide per tablet) provided by Shandong Ruzhi Biopharmaceutical Technology Co., Ltd. and candesartan cilexetil tablets (containing 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide per tablet, trade name: Blopress®) certified by CHEPHAPHARM Arzneimittel GmbH in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of candesartan cilexetil tablets (containing 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide per tablet) provided by Shandong Ruzhi Biopharmaceutical Technology Co., Ltd. and candesartan cilexetil tablets (containing 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide per tablet, trade name: Blopress®) certified by CHEPHAPHARM Arzneimittel GmbH in healthy adults under fasting and postprandial administration conditions.

Start Date-

Sponsor / Collaborator

Shandong Ruzhi Biomedical Technology Co., Ltd.

CTR20242008

/ Not yet recruitingNot Applicable

乙酰半胱氨酸口服溶液在健康受试者空腹和餐后状态下的单中心、随机、开放、两制剂、两序列、两周期、单次、交叉给药生物等效性研究

[Translation] A single-center, randomized, open-label, two-formulation, two-sequence, two-period, single-dose, crossover bioequivalence study of acetylcysteine oral solution in healthy volunteers under fasting and fed conditions

主要目的：研究空腹和餐后状态下健康志愿者口服受试制剂乙酰半胱氨酸口服溶液与参比制剂乙酰半胱氨酸口服溶液（商品名：Fluimucil ®）的体内药代动力学特征，评价空腹和餐后状态给药时两种制剂的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To study the in vivo pharmacokinetic characteristics of the test preparation acetylcysteine oral solution and the reference preparation acetylcysteine oral solution (trade name: Fluimucil ®) in healthy volunteers in the fasting and fed state, and to evaluate the bioequivalence of the two preparations when administered in the fasting and fed state. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date-

Sponsor / Collaborator

Shandong Ruzhi Biomedical Technology Co., Ltd.

100 Clinical Results associated with Shandong Ruzhi Biomedical Technology Co., Ltd.

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0 Patents (Medical) associated with Shandong Ruzhi Biomedical Technology Co., Ltd.

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100 Deals associated with Shandong Ruzhi Biomedical Technology Co., Ltd.

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100 Translational Medicine associated with Shandong Ruzhi Biomedical Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 03 Aug 2025

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

Discovery

3

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