[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of benidipine hydrochloride tablets (4 mg) in Chinese healthy subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择Kyowa Kirin Co., Ltd.为持证商的盐酸贝尼地平片（商品名：可力洛，规格：4mg）为参比制剂，对石家庄四药有限公司持证的受试制剂盐酸贝尼地平片（规格：4mg）进行空腹条件下给药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盐酸贝尼地平片（规格：4mg）和参比制剂盐酸贝尼地平片（商品名：可力洛，规格：4mg）的安全性。

[Translation]

Main purpose of study: According to the relevant provisions of bioequivalence test, benidipine hydrochloride tablets (trade name: kelilol, specification: 4mg) licensed by Kyowa Kirin Co., Ltd. were selected as the reference preparation, and the test preparation benidipine hydrochloride tablets (specification: 4mg) licensed by Shijiazhuang Siyao Co., Ltd. were subjected to human bioequivalence test under fasting conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary purpose of study: To observe the safety of oral administration of the test preparation benidipine hydrochloride tablets (specification: 4mg) and the reference preparation benidipine hydrochloride tablets (trade name: kelilol, specification: 4mg) to healthy subjects.

Start Date14 Aug 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20242740 / CompletedNot Applicable

盐酸贝尼地平片（4mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Kyowa Kirin Co., Ltd.为持证商的盐酸贝尼地平片（商品名：可力洛，规格：4mg）为参比制剂，对石家庄四药有限公司持证的受试制剂盐酸贝尼地平片（规格：4mg）进行餐后条件下给药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盐酸贝尼地平片（规格：4mg）和参比制剂盐酸贝尼地平片（商品名：可力洛，规格：4mg）的安全性。

[Translation]

Main purpose of study: According to the relevant provisions of bioequivalence test, benidipine hydrochloride tablets (trade name: kelilol, specification: 4mg) licensed by Kyowa Kirin Co., Ltd. were selected as the reference preparation, and the test preparation benidipine hydrochloride tablets (specification: 4mg) licensed by Shijiazhuang Siyao Co., Ltd. were subjected to human bioequivalence test under postprandial conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions. Secondary purpose of study: To observe the safety of oral administration of the test preparation benidipine hydrochloride tablets (specification: 4mg) and the reference preparation benidipine hydrochloride tablets (trade name: kelilol, specification: 4mg) to healthy subjects.

Start Date12 Aug 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20242268 / CompletedNot Applicable

盐酸贝尼地平片（8 mg）在健康受试者中的空腹/餐后生物等效性试验

[Translation] Fasting/fed bioequivalence study of benidipine hydrochloride tablets (8 mg) in healthy subjects

主要目的：在健康受试者中，评价Kyowa Kirin Co., Ltd.持证的参比制剂盐酸贝尼地平片（可力洛，8 mg）与浙江华海药业股份有限公司生产受试制剂的盐酸贝尼地平片（8 mg）在空腹和餐后条件下的生物等效性。次要目的：观察受试制剂盐酸贝尼地平片与参比制剂盐酸贝尼地平片（可力洛）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the reference preparation benidipine hydrochloride tablets (collilol, 8 mg) certified by Kyowa Kirin Co., Ltd. and the test preparation benidipine hydrochloride tablets (8 mg) produced by Zhejiang Huahai Pharmaceutical Co., Ltd. under fasting and fed conditions in healthy subjects. Secondary objective: To observe the safety of the test preparation benidipine hydrochloride tablets and the reference preparation benidipine hydrochloride tablets (collilol) in healthy subjects.

Start Date17 Jul 2024

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

100 Clinical Results associated with Benidipine Hydrochloride

100 Translational Medicine associated with Benidipine Hydrochloride

100 Patents (Medical) associated with Benidipine Hydrochloride

357

Literatures (Medical) associated with Benidipine Hydrochloride

31 Dec 2024·Drug Delivery

Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performance

Article

Author: Rahamathulla, Mohamed ; Ahmed, Mohammed Muqtader ; Buddhadev, Sheetal S ; Farhana, Syeda Ayesha ; C Garala, Kevinkumar ; Pasha, Ismail ; S, Saisivam

The primary objective of the research effort is to establish efficient solid self-nanoemulsifying drug delivery systems (S-SNEDDS) for benidipine (BD) through the systematic application of a quality-by-design (QbD)-based paradigm. Utilizing Labrafil M 2125 CS, Kolliphor EL, and Transcutol P, the BD-S-SNEDDS were created. The central composite design was adopted to optimize numerous components. Zeta potential, drug concentration, resistance to dilution, pH, refractive index, viscosity, thermodynamic stability, and cloud point were further investigated in the most efficient formulation, BD14, which had a globule size of 156.20 ± 2.40 nm, PDI of 0.25, zeta potential of -17.36 ± 0.18 mV, self-emulsification time of 65.21 ± 1.95 s, % transmittance of 99.80 ± 0.70%, and drug release of 92.65 ± 1.70% at 15 min. S-SNEDDS were formulated using the adsorption process and investigated via Fourier transform infrared spectroscopy, Differential scanning calorimeter, Scanning electron microscopy, and powder X-ray diffraction. Optimized S-SNEDDS batch BD14 dramatically decreased blood pressure in rats in contrast to the pure drug and the commercial product, according to a pharmacodynamics investigation. Accelerated stability tests validated the product's stability. Therefore, the development of oral S-SNEDDS of BD may be advantageous for raising BD's water solubility and expanding their releasing capabilities, thereby boosting oral absorption.

01 Nov 2024·Journal of Cardiology Cases

Refractory vasospastic angina in a patient with autoimmune hepatitis managed by using combined non-invasive provocation tests: A case report

Article

Author: Fujii, Masayoshi ; Hiranuma, Noritoshi ; Fujimoto, Yuhna ; Ohashi, Yoshitaka

Corticosteroids have emerged as a feasible treatment option for patients with refractory vasospastic angina (VSA) who have an allergic disease or hypereosinophilia. However, reports on VSA following the administration of corticosteroids are scarce. Herein, we present the rare case of a 49-year-old Japanese man who developed VSA while receiving corticosteroids for treatment of autoimmune hepatitis. Invasive coronary angiography and pharmacological spasm provocation tests under oral prednisolone (20 mg) revealed multi-vessel spasms with ST elevation but no obstructed coronary arteries. To assess the effectiveness of the pharmacotherapy following a Ca²⁺ antagonist (benidipine) administration, we adopted non-invasive and non-pharmacological coronary vasospasm provocation tests (cold-pressor stress, isometric handgrip exercise, and hyperventilation). These tests revealed transient ST elevations with angina, which prompted us to add other vasodilators to control the high disease activity. These tests can be particularly valuable in cases where spasmogenicity fluctuates with changes in corticosteroid dosage during prolonged treatment of hepatitis.Learning objectiveCorticosteroids can induce vasospastic angina (VSA) and corticosteroid-induced VSA may relapse in a dose-dependent manner. Discontinuation of corticosteroids is often difficult, and long-term administration may be inevitable. Evaluation of the fluctuated spasmogenicity during long-term observation of autoimmune hepatitis may be crucial.

01 Aug 2024·Naunyn-Schmiedeberg's Archives of Pharmacology

Anti-inflammatory activity of benidipine hydrochloride in LPS-activated mammalian macrophages

Article

Author: Korkmaz, Tanya Beril ; Ayaz, Furkan ; Servi, Hülya

AbstractBenidipine hydrochloride (BH), a medication frequently used by the hypertension patients, acts as a calcium channel blocker. However, its effects on the macrophages have not been investigated thus far. Our goal was investigating the effect of the benidipine hydrochloride to modulate the J774.2 murine macrophage cells inflammatory activity. Our results suggest that in the absence of a standard stimulating agent (LPS) BH did not stimulate the macrophages to produce pro-inflammatory IL-12p40, TNF-α, GM-CSF and IL-6 cytokines. However, when BH was administrated to the cells in the presence of LPS as stimulating agent, it reduced the production of these pro-inflammatory cytokines. Therefore, it had anti-inflammatory activity. At the clinical setting this study suggests that BH can be utilized as hypertension drug that can suppress the inflammation associated with it.

100 Deals associated with Benidipine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02045	Benidipine Hydrochloride	C08CA15	DB09231

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	CN	Shandong Huasu Pharmaceutical Co., Ltd.	29 Jan 2003
Parenchymal renal hypertension	JP	Kyowa Kirin Co., Ltd.	01 Jun 1994
Angina Pectoris	JP	Kyowa Kirin Co., Ltd.	04 Oct 1991

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00135551 (COPE Trial, Pubmed)	Phase 4	Hypertension	3,501	Benidipine + Thiazide	dcsyydfedo(avepvyfwlt) = sgocusnmbp beijskmvmq (erluazgygd ) View more	-	29 Jan 2020
				Benidipine + β-blocker	dcsyydfedo(avepvyfwlt) = kyurilixnx beijskmvmq (erluazgygd ) View more

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