HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors), NPC1L1 inhibitors(Niemann-Pick C1-like protein 1 inhibitors), Cholesterol absorption inhibitors

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Hypercholesterolemia

Inactive Indication-

Originator Organization

Zhejiang Hisun Pharmaceutical Co., Ltd.

Active Organization

Hanhui Pharmaceutical Co. Ltd. (China)

Inactive Organization

Zhejiang Hisun Pharmaceutical Co., Ltd.

Drug Highest PhaseIND Approval

First Approval Date-

Regulation-

Structure

Molecular FormulaC66H76CaF2N4O13

InChIKeyHIZONJHAVINWOX-NIJVSVLQSA-N

CAS Registry344423-98-9

View All Structures (2)

Clinical Trials associated with Atorvastatin Calcium Hydrate/Hyzetimibe

CTR20242451 / RecruitingNot Applicable

海博麦布阿托伐他汀钙片在健康受试者中的随机、开放、单剂量、四周期、两序列完全重复交叉的餐后生物等效性研究

[Translation] A randomized, open-label, single-dose, four-period, two-sequence complete repeated crossover postprandial bioequivalence study of Hebomib atorvastatin calcium tablets in healthy volunteers

本试验旨在研究餐后单次口服瀚晖制药有限公司研制、浙江海正药业股份有限公司生产的海博麦布阿托伐他汀钙片（20 mg/10 mg）的药代动力学特征；以浙江海正药业股份有限公司生产的海博麦布片（赛斯美®，20 mg）及辉瑞制药有限公司生产的阿托伐他汀钙片（立普妥®，10 mg）联用作为对照，比较海博麦布阿托伐他汀钙片与海博麦布片和阿托伐他汀钙片联用的药动学参数〔总海博麦布（海博麦布+海博麦布-葡萄糖醛酸结合物）、海博麦布、阿托伐他汀：Cmax、AUC0-t、AUC0-∞〕，评价海博麦布阿托伐他汀钙片与海博麦布片和阿托伐他汀钙片联用的人体生物等效性。次要目的：评价海博麦布阿托伐他汀钙片在健康成年受试者中的安全性。

[Translation]

This study aims to study the pharmacokinetic characteristics of Hebomib Atorvastatin Calcium Tablets (20 mg/10 mg) developed by Hanhui Pharmaceutical Co., Ltd. and produced by Zhejiang Hisun Pharmaceutical Co., Ltd. after a single oral administration after a meal; using Hebomib Tablets (Cesme®, 20 mg) produced by Zhejiang Hisun Pharmaceutical Co., Ltd. and Atorvastatin Calcium Tablets (Lipitor®, 10 mg) produced by Pfizer Pharmaceuticals Co., Ltd. as controls, to compare the pharmacokinetic parameters of Hebomib Atorvastatin Calcium Tablets and Hebomib Tablets and Atorvastatin Calcium Tablets in combination [total Hebomib (Hebomib + Hebomib-glucuronic acid conjugate), Hebomib, Atorvastatin: Cmax, AUC0-t, AUC0-∞], and to evaluate the bioequivalence of Hebomib Atorvastatin Calcium Tablets and Hebomib Tablets and Atorvastatin Calcium Tablets in humans. Secondary objective: To evaluate the safety of Hebomib Atorvastatin Calcium Tablets in healthy adult subjects.

Start Date23 Jul 2024

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+1]

CTR20232954 / CompletedNot Applicable

海博麦布阿托伐他汀钙片在健康受试者中的随机、开放、单剂量、四周期、两序列完全重复交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, four-period, two-sequence complete repeated crossover bioequivalence study of Hebomib atorvastatin calcium tablets in healthy subjects

主要目的：研究空腹和餐后单次口服瀚晖制药有限公司研制的海博麦布阿托伐他汀钙片（20 mg/10 mg）的药代动力学特征；以浙江海正药业股份有限公司生产的海博麦布片（赛斯美®，20 mg）及辉瑞制药有限公司生产的阿托伐他汀钙片（立普妥®，10 mg）联用作为对照，评价海博麦布阿托伐他汀钙片与海博麦布片和阿托伐他汀钙片联用的人体生物等效性。次要目的：评价海博麦布阿托伐他汀钙片在健康成年受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetic characteristics of Hebomib Atorvastatin Calcium Tablets (20 mg/10 mg) developed by Hanhui Pharmaceutical Co., Ltd. after single oral administration on an empty stomach and after meals; to evaluate the bioequivalence of Hebomib Atorvastatin Calcium Tablets with Hebomib Tablets and Atorvastatin Calcium Tablets in combination, using Hebomib Tablets (Cesme®, 20 mg) produced by Zhejiang Hisun Pharmaceutical Co., Ltd. and Atorvastatin Calcium Tablets (Lipitor®, 10 mg) produced by Pfizer Pharmaceuticals Co., Ltd. as controls. Secondary objective: To evaluate the safety of Hebomib Atorvastatin Calcium Tablets in healthy adult subjects.

Start Date09 Oct 2023

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Atorvastatin Calcium Hydrate/Hyzetimibe

100 Translational Medicine associated with Atorvastatin Calcium Hydrate/Hyzetimibe

100 Patents (Medical) associated with Atorvastatin Calcium Hydrate/Hyzetimibe

100 Deals associated with Atorvastatin Calcium Hydrate/Hyzetimibe

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hypercholesterolemia	Phase 1	-	Zhejiang Hisun Pharmaceutical Co., Ltd.	28 Feb 2015

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