考察餐后条件下，健康受试者单次口服由宁波科尔康美诺华药业有限公司提供的坎地氢噻片（受试制剂，规格：每片含坎地沙坦酯16mg，氢氯噻嗪12.5mg）与单次口服由CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片（参比制剂，规格：每片含坎地沙坦酯16mg，氢氯噻嗪12.5mg）的药动学特征，评价两制剂间的生物等效性及安全性，为受试制剂的注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of candesartan cilexetil tablets (test preparation, specification: each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide) provided by Ningbo Keer Kangmei Novartis Pharmaceuticals Co., Ltd. and candesartan cilexetil tablets (reference preparation, specification: each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide) certified by CHEPLAPHARM Arzneimittel GmbH in healthy subjects after a single oral administration under postprandial conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Start Date16 Sep 2024

Sponsor / Collaborator

Ningbo Krka Menovo Pharmaceutical Co., Ltd.

CTR20242966 / CompletedNot Applicable

坎地氢噻片在空腹条件下的人体生物等效性试验

[Translation] Bioequivalence study of candecitabine tablets in human subjects under fasting conditions

考察空腹条件下，健康受试者单次口服由宁波科尔康美诺华药业有限公司提供的坎地氢噻片（受试制剂，规格：每片含坎地沙坦酯16mg，氢氯噻嗪12.5mg）与单次口服由CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片（参比制剂，规格：每片含坎地沙坦酯16mg，氢氯噻嗪12.5mg）的药动学特征，评价两制剂间的生物等效性及安全性，为受试制剂的注册申请提供依据

[Translation]

To investigate the pharmacokinetic characteristics of a single oral administration of Candesartan cilexetil tablets (test preparation, specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) provided by Ningbo Keer Kangmei Novartis Pharmaceutical Co., Ltd. and a single oral administration of Candesartan cilexetil tablets (reference preparation, specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) certified by CHEPLAPHARM Arzneimittel GmbH in healthy subjects under fasting conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Start Date03 Sep 2024

Sponsor / Collaborator

Ningbo Krka Menovo Pharmaceutical Co., Ltd.

CTR20242284 / CompletedNot Applicable

坎地氢噻片在健康受试者中空腹/餐后、单中心、单次口服给药、随机、开放、两序列、两周期、两交叉生物等效性试验

[Translation] A single-center, single-dose, randomized, open-label, two-sequence, two-period, two-crossover bioequivalence study of candecyrrhizic tablets in healthy subjects after fasting or after meals

主要目的：考察中国健康受试者在空腹/餐后条件下单次口服海南药谷云生物科技有限公司持有，江苏诚康药业有限公司生产的坎地氢噻片（规格：每片含坎地沙坦酯16mg和氢氯噻嗪12.5mg）与CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片（商品名：Blopress®，规格：每片含坎地沙坦酯16mg和氢氯噻嗪12.5mg）后的体内药代动力学特征，评价两制剂的生物等效性。次要目的：评价单剂量口服坎地氢噻片受试制剂及参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of candesartan cilexetil tablets (specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) owned by Hainan Yaoguyun Biotechnology Co., Ltd. and produced by Jiangsu Chengkang Pharmaceutical Co., Ltd. and candesartan cilexetil tablets (trade name: Blopress®, specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) licensed by CHEPLAPHARM Arzneimittel GmbH in healthy Chinese subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test and reference preparations of candesartan cilexetil tablets taken orally at a single dose in healthy Chinese subjects.

Start Date22 Jul 2024

Sponsor / Collaborator

Hai Nan Yao Gu Yun Sheng Wu Ke Ji You Xian Gong Si

100 Clinical Results associated with Candesartan Cilexetil/Hydrochlorothiazide

100 Translational Medicine associated with Candesartan Cilexetil/Hydrochlorothiazide

100 Patents (Medical) associated with Candesartan Cilexetil/Hydrochlorothiazide

Literatures (Medical) associated with Candesartan Cilexetil/Hydrochlorothiazide

01 Sep 2013·Pain PracticeQ3 · MEDICINE

Migraine Treated Using a Prophylactic Combination of Candesartan and Hydrochlorothiazide (ECARD^® Combination Tablets LD)

Q3 · MEDICINE

Article

Author: Hasegawa, Yasuhiro ; Akiyama, Hisanao

AbstractWe describe the use of the antihypertensive, candesartan, with hydrochlorothiazide (ECARD® Combination Tablets LD) as a preventive therapy that decreased the frequency of migraine accompanied by premonitory leg edema. Two women (aged 26 and 50 years) presented to hospital with an increasing frequency of migraine without aura accompanied by leg edema. We prescribed ECARD® half tablet (candesartan, 2 mg and hydrochlorothiazide, 3.125 mg), and the migraines and leg edema disappeared. The use of ECARD® to treat a series of migraines by controlling premonitory leg edema has not been reported. ECARD®, combined with a low‐dose diuretic, may have been helpful in these patients with the premonitory migraine symptom of leg edema.

01 Jan 2009·Folia Pharmacologica Japonica

Pharmacological and clinical properties of ECARD® combination tablets LD & HD, fixed-dose combination of candesartan cilexetil and hydrochlorothiazide

Review

Author: Junichi Tanokashira ; Nobuo Totsuka ; Mitsuhiro Mori ; Keiji Kusumoto

A review on concept of development of Ecard combination tablets, and pharmacol. effect including angiotensin II antagonizing effect of candesartan cilexetil referring to binding inhibitory effect on human AT₁ receptor, mode of suppression of angiotensin II-mediated contraction of rabbit isolated blood vessel, and antihypertensive effect in various hypertensive model in rats, and antihypertensive effect and diuretic effect of combination of candesartan cilexetil and hydrochlorothiazide.Also reviewed are results of clin. studies including phase III double-blind study, phase III long-term study, and pharmacokinetic study of Ecard combination tablets HD administered orally repeatedly for 15 days to light to mild essential hypertensive Japanese patients.

100 Deals associated with Candesartan Cilexetil/Hydrochlorothiazide

External Link

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R&D Status

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Indication	Country/Location	Organization	Date
Hypertension	US	ANI Pharmaceuticals, Inc.	05 Sep 2000

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