Delving into the Latest Updates on Amlodipine Besylate/Telmisartan with Synapse

主要研究目的：按有关生物等效性试验的规定，选择 Boehringer Ingelheim International GmbH 为持证商，天津掌心医药科技有限公司提供的替米沙坦氨氯地平片（商品名：Twynsta®，规格：80mg/5mg）为参比制剂，对淄博万杰制药有限公司生产并提供的受试制剂替米沙坦氨氯地平片（规格：80mg/5mg）进行空腹和餐后给药条件下的人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂替米沙坦氨氯地平片（规格：80mg/5mg）和参比制剂替米沙坦氨氯地平片（商品名：Twynsta®，规格：80mg/5mg）的安全性。

[Translation]

Main purpose of study: According to the relevant provisions of bioequivalence test, Boehringer Ingelheim International GmbH was selected as the licensee, and Telmisartan Amlodipine Tablets (trade name: Twynsta®, specification: 80mg/5mg) provided by Tianjin Palm Pharmaceutical Technology Co., Ltd. was selected as the reference preparation. The human bioequivalence test of the test preparation Telmisartan Amlodipine Tablets (specification: 80mg/5mg) produced and provided by Zibo Wanjie Pharmaceutical Co., Ltd. was conducted under fasting and postprandial administration conditions to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose of study: To observe the safety of oral administration of the test preparation Telmisartan Amlodipine Tablets (specification: 80mg/5mg) and the reference preparation Telmisartan Amlodipine Tablets (trade name: Twynsta®, specification: 80mg/5mg) in healthy subjects.

Start Date13 Jun 2024

Sponsor / Collaborator

Shengjia (Binhai) Biomedical Technology Co., Ltd.

CTR20240509 / CompletedNot Applicable

替米沙坦氨氯地平片人体生物等效性研究（餐后）

[Translation] Bioequivalence study of telmisartan and amlodipine tablets in healthy volunteers (after meal)

按有关生物等效性试验的规定，选择Boehringer Ingelheim International GmbH为持证商的替米沙坦氨氯地平片（商品名：Twynsta®，规格：每片含替米沙坦80mg，氨氯地平5mg）为参比制剂，对长春海悦药业股份有限公司持证的受试制剂替米沙坦氨氯地平片（规格：每片含替米沙坦80mg，氨氯地平5mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在餐后给药条件下的生物等效性。

[Translation]

In accordance with the relevant provisions of bioequivalence tests, Telmisartan Amlodipine Tablets (trade name: Twynsta®, specification: each tablet contains 80 mg of telmisartan and 5 mg of amlodipine) certified by Boehringer Ingelheim International GmbH were selected as the reference preparation, and the test preparation Telmisartan Amlodipine Tablets (specification: each tablet contains 80 mg of telmisartan and 5 mg of amlodipine) certified by Changchun Haiyue Pharmaceutical Co., Ltd. were subjected to a human bioequivalence study after meal administration. The differences in the absorption rate and extent of the drug in the test preparation and the reference preparation were compared to see whether they were within an acceptable range, and the bioequivalence of the two preparations under the condition of postprandial administration was evaluated.

Start Date10 Jun 2024

Sponsor / Collaborator

Changchun Haiyue Pharmaceutical Co., Ltd

CTR20240972 / CompletedNot Applicable

替米沙坦氨氯地平片在健康受试者空腹和餐后状态下的随机、开放、单剂量、两制剂、三序列、三周期、部分重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, three-sequence, three-period, partially repeated crossover bioequivalence study of telmisartan and amlodipine tablets in healthy volunteers under fasting and fed conditions

主要目的：比较空腹和餐后单次给药条件下，苏州东瑞制药有限公司生产的替米沙坦氨氯地平片（规格：每片含替米沙坦 80mg 与苯磺酸氨氯地平 5mg（按照氨氯地平计算），受试制剂）与 Boehringer Ingelheim International GmbH 持证的替米沙坦氨氯地平片（商品名：Twynsta®，规格：每片含替米沙坦 80mg 与苯磺酸氨氯地平 5mg（按照氨氯地平计算），参比制剂）在健康受试者中吸收程度和速度的差异。通过主要药代动力学参数，评价两者是否生物等效。次要目的：通过观察健康受试者单次口服受试制剂和参比制剂后的安全性指标，评价替米沙坦氨氯地平片的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of Telmisartan Amlodipine Tablets (Specification: Each tablet contains 80 mg of Telmisartan and 5 mg of Amlodipine Besylate (calculated as Amlodipine), test preparation) produced by Suzhou Dongrui Pharmaceutical Co., Ltd. and Telmisartan Amlodipine Tablets (Trade name: Twynsta®, Specification: Each tablet contains 80 mg of Telmisartan and 5 mg of Amlodipine Besylate (calculated as Amlodipine), reference preparation) certified by Boehringer Ingelheim International GmbH in healthy subjects under the conditions of single administration on an empty stomach and after a meal. To evaluate whether the two are bioequivalent by the main pharmacokinetic parameters. Secondary objective: To evaluate the safety of Telmisartan Amlodipine Tablets by observing the safety indicators of the test preparation and reference preparation after a single oral administration in healthy subjects.

Start Date29 May 2024

Sponsor / Collaborator

Suzhou Dawnrays Pharmaceutical Co., Ltd.

100 Clinical Results associated with Amlodipine Besylate/Telmisartan

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100 Translational Medicine associated with Amlodipine Besylate/Telmisartan

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100 Patents (Medical) associated with Amlodipine Besylate/Telmisartan

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3

Literatures (Medical) associated with Amlodipine Besylate/Telmisartan

01 Dec 2017·International Journal of PharmaceuticsQ2 · MEDICINE

Quality by Design (QbD) approach to optimize the formulation of a bilayer combination tablet (Telmiduo®) manufactured via high shear wet granulation

Q2 · MEDICINE

Article

Author: Lee, Ah Ram ; Kwon, Seok Young ; Choi, Du Hyung ; Park, Eun Seok

A bilayer tablet, which consisted of telmisartan and amlodipine besylate, was formulated based on a Quality by Design (QbD) approach. The control and response factors were determined based on primary knowledge and the target values of the control tablet (Twynsta^®). A D-optimal mixture design was used to obtain the optimal formulations in terms of D-mannitol, crospovidone, and MCC for the telmisartan layer, and CCM-Na, PVP K25, and Prosolv for the amlodipine layer. The quantitative effects of the different formulation factors on the response factors were accurately predicted using the equations of best fit and a strong linearity was observed between the predicted and actual values of the response factors. The optimized bilayer tablet was obtained using a numeric optimization technique and was characterized compared with a control (Twynsta^®) by using various physical evaluations and in vivo pharmacokinetic parameters. The physical stability of Telmiduo^® was greater than that of Twynsta^® owing to the improvement of formulation factors. The in vivo pharmacokinetic parameters suggested that Telmiduo^® might have pharmaceutical equivalence and bioequivalence with Twynsta^®. Therefore, the bilayer tablet that consisted of telmisartan and amlodipine besylate could be produced using a more economical and simpler method than that used to produce Twynsta^®. Moreover, the suitability of QbD for effective product development in the pharmaceutical industry was shown.

11 Jan 2010·The Medical letter on drugs and therapeuticsQ4 · MEDICINE

A third amlodipine/ARB combination (Twynsta) for hypertension.

Q4 · MEDICINE

Article

01 Jan 2010·JAAPA : official journal of the American Academy of Physician AssistantsQ4 · MEDICINE

New drug information: Twynsta 40 mg/5mg.

Q4 · MEDICINE

Article

100 Deals associated with Amlodipine Besylate/Telmisartan

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	LI	Boehringer Ingelheim International GmbH	07 Oct 2010
Essential Hypertension	IS	Boehringer Ingelheim International GmbH	07 Oct 2010
Essential Hypertension	EU	Boehringer Ingelheim International GmbH	07 Oct 2010
Essential Hypertension	NO	Boehringer Ingelheim International GmbH	07 Oct 2010
Hypertension	JP	Nippon Boehringer Ingelheim Co., Ltd.	23 Jul 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 2	MX	Boehringer Ingelheim GmbH	01 May 2010
Hypertension	Phase 2	US	Boehringer Ingelheim Pharmaceuticals, Inc.	16 Oct 2009

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Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03566316 (Pubmed)	Phase 3	Hyperlipidemias \| Hypertension	134	telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg	(mlsdtjpcud) = adltapznoe bxwjsxcysn (kfjegqcvxp ) View more	-	01 Apr 2019
NCT03566316 (Pubmed)	Phase 3	Hyperlipidemias \| Hypertension	134	telmisartan/amlodipine 80/10 mg	(mlsdtjpcud) = vinlbmvabr bxwjsxcysn (kfjegqcvxp )	-	01 Apr 2019
NCT01975246 (CTgov)	Phase 3	Hypertension	309	Placebo+Telmisartan + amlodipine	vmmrqibgzm(rgfijlwrzl) = fihosdeeih osvrpznczy (ahazrotqhs, okitkvoego - iphqkfzjqx) View more	-	29 Nov 2016