[Translation] A randomized, double-blind, double-dummy, multicenter phase III clinical study on the efficacy and safety of candesartan cilexetil amlodipine tablets (8mg/5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by candesartan cilexetil tablets (8mg) or amlodipine besylate tablets (5mg) alone for 4 weeks.

验证复方制剂相对于单方制剂的优效性。评价复方坎地沙坦酯氨氯地平片（8mg/5mg）用于坎地沙坦酯片（8mg）或苯磺酸氨氯地平片（5mg）单药治疗4周血压不能有效控制的原发性轻、中度高血压的有效性和安全性。

[Translation]

To verify the superiority of the compound preparation over the single preparation. To evaluate the efficacy and safety of compound candesartan cilexetil amlodipine tablets (8mg/5mg) in the treatment of primary mild and moderate hypertension whose blood pressure cannot be effectively controlled by candesartan cilexetil tablets (8mg) or amlodipine besylate tablets (5mg) for 4 weeks.

Start Date28 Aug 2024

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

CTR20242696

/ CompletedNot Applicable

坎地沙坦酯氨氯地平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 candesartan cilexetil and amlodipine tablets in healthy subjects under fasting and fed conditions

主要研究目的比较空腹和餐后给药条件下，福安药业集团庆余堂制药有限公司生产的坎地沙坦酯氨氯地平片（8mg/5mg）与武田薬品工業株式会社持证的坎地沙坦酯氨氯地平片（8mg/5mg，商品名：UNISIA® Combination Tablets）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。次要研究目的评价空腹和餐后给药条件下，福安药业集团庆余堂制药有限公司生产的坎地沙坦酯氨氯地平片（8mg/5mg）与武田薬品工業株式会社持证的坎地沙坦酯氨氯地平片（8mg/5mg，商品名：UNISIA® Combination Tablets）在健康成年人群中的安全性。

[Translation]

Main research purpose Comparing the fasting and postprandial administration conditions, candesartan cilexetil amlodipine tablets (8mg/5mg) produced by Fuan Pharmaceutical Group Qingyutang Pharmaceutical Co., Ltd. and candesartan cilexetil licensed by Takeda Pharmaceutical Co., Ltd. Differences in the extent and rate of absorption of amlodipine tablets (8mg/5mg, trade name: UNISIA® Combination Tablets) in healthy adult populations to evaluate their bioequivalence. Secondary research purpose Evaluation of candesartan cilexetil amlodipine tablets (8mg/5mg) produced by Fuan Pharmaceutical Group Qingyutang Pharmaceutical Co., Ltd. and candesartan cilexetil licensed by Takeda Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions Safety of amlodipine tablets (8mg/5mg, trade name: UNISIA® Combination Tablets) in healthy adults.

Start Date22 Aug 2024

Sponsor / Collaborator

Chongqing Qingyutang Pharmaceutical Co. Ltd.

CTR20232353

/ CompletedNot Applicable

单中心、随机、开放、两周期、双交叉设计评价中国健康受试者单次空腹及餐后口服坎地沙坦酯氨氯地平片的人体生物等效性试验。

[Translation] A single-center, randomized, open-label, two-period, double-crossover design was used to evaluate the bioequivalence of candesartan cilexetil and amlodipine tablets in Chinese healthy subjects after single fasting and postprandial oral administration.

主要目的：以日本武田テバ薬品株式会社生产的坎地沙坦酯氨氯地平片（商品名：UNISIA；规格：坎地沙坦酯8mg与苯磺酸氨氯地平（按氨氯地平计）5mg）为参比制剂，以江西施美药业股份有限公司研发的坎地沙坦酯氨氯地平片（规格：坎地沙坦酯8mg与苯磺酸氨氯地平（按氨氯地平计）5mg）为受试制剂，通过单中心、随机、开放、两周期、双交叉设计的生物等效性试验来评价两种制剂在空腹及餐后条件下的生物等效性。次要目的：评估受试制剂坎地沙坦酯氨氯地平片和参比制剂UNISIA在中国健康成年受试者中的安全性。

[Translation]

Primary objective: Using candesartan cilexetil-amlodipine tablets (trade name: UNISIA; specification: candesartan cilexetil 8 mg and amlodipine besylate (calculated as amlodipine) 5 mg) produced by Takeda Teba Pharmaceutical Co., Ltd. of Japan as the reference preparation, and candesartan cilexetil-amlodipine tablets (specification: candesartan cilexetil 8 mg and amlodipine besylate (calculated as amlodipine) 5 mg) developed by Jiangxi Shimei Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, two-period, double-crossover bioequivalence study was conducted to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions. Secondary objective: To evaluate the safety of the test preparation candesartan cilexetil-amlodipine tablets and the reference preparation UNISIA in healthy adult subjects in China.

Start Date28 Aug 2023

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

100 Clinical Results associated with Amlodipine Besylate/Candesartan Cilexetil

100 Translational Medicine associated with Amlodipine Besylate/Candesartan Cilexetil

100 Patents (Medical) associated with Amlodipine Besylate/Candesartan Cilexetil

100 Deals associated with Amlodipine Besylate/Candesartan Cilexetil

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Essential Hypertension	South Korea	MYUNGMOON Pharm Co., Ltd.	22 Jul 2025
Hypertension	Japan	T’s Pharma Co., Ltd.	06 Apr 2010
Hypertension	Japan	Takeda Pharmaceutical Co., Ltd.	06 Apr 2010

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Dyslipidemias	Phase 3	United States	Chong Kun Dang Pharmaceutical Corp.	04 Apr 2018
Cardiovascular Diseases	Phase 1	-	Chong Kun Dang Pharmaceutical Corp.	01 Nov 2020
Hyperlipidemias	Phase 1	United States	Chong Kun Dang Pharmaceutical Corp.	01 Dec 2016

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