[Translation] A randomized, open-label, single-dose, four-period, completely repeated crossover bioequivalence study of minodronic acid tablets under fasting conditions

主要研究目的：以アステラス製薬株式会社生产的米诺膦酸片（商品名：Bonoteo，规格：1mg/片）为参比制剂，以安徽博诺美科生物医药有限公司提供的米诺膦酸片（规格：1mg/片）为受试制剂，采用随机、开放、单剂量、四周期、完全重复交叉设计，比较受试者空腹状态下服用受试制剂与参比制剂后米诺膦酸的吸收速度与程度，评价两制剂在中国健康受试者中空腹状态下的生物等效性。次要研究目的：评价中国健康受试者口服受试制剂米诺膦酸片（规格：1mg/片）和参比制剂米诺膦酸片（商品名：Bonoteo，规格：1mg/片）的安全性。

[Translation]

Main research purpose: Use minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) produced by Aisuo Biotech Co., Ltd. as the reference preparation, and use minodronic acid provided by Anhui Bonomeco Biopharmaceutical Co., Ltd. The tablet (specification: 1 mg/tablet) is the test preparation. A randomized, open-label, single-dose, four-cycle, fully repeated crossover design was adopted to compare the effects of minodronic acid after subjects took the test preparation and the reference preparation in the fasting state. The absorption rate and extent were evaluated to evaluate the bioequivalence of the two preparations in Chinese healthy subjects under fasting state. Secondary research purpose: To evaluate the safety of the test preparation minodronic acid tablets (specification: 1mg/tablet) and the reference preparation minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) orally administered to Chinese healthy subjects sex.

Start Date28 Oct 2024

Sponsor / Collaborator

Anhui Bonomic Biomedical Co., Ltd.

CTR20243020 / RecruitingNot Applicable

米诺膦酸片（1mg）空腹人体生物等效性研究

[Translation] Bioequivalence study of minodronic acid tablets (1 mg) in fasting volunteers

以山东新时代药业有限公司生产的米诺膦酸片（规格：1mg）为受试制剂，アステラス製薬株式会社持证的米诺膦酸片（商品名：Bonoteo，规格：1mg）为参比制剂，考察两制剂在空腹状态下单次给药吸收速度和程度的差异，评价两制剂是否具有生物等效性。

[Translation]

The minodronic acid tablets (specification: 1mg) produced by Shandong New Times Pharmaceutical Co., Ltd. were used as the test preparation, and the minodronic acid tablets (trade name: Bonoteo, specification: 1mg) licensed by Aisu Pharmaceutical Co., Ltd. were used as the reference. Compare the preparations and examine the difference in absorption rate and degree of single administration between the two preparations in the fasting state to evaluate whether the two preparations are bioequivalent.

Start Date23 Sep 2024

Sponsor / Collaborator

Shandong New Time Pharmaceutical Co. Ltd.

CTR20244031 / CompletedNot Applicable

米诺膦酸片在空腹给药条件下随机、开放、单剂量、四周期、完全重复交叉生物等效性预试验

[Translation] A randomized, open-label, single-dose, four-period, completely repeated crossover bioequivalence pilot study of minodronic acid tablets under fasting conditions

主要研究目的：以アステラス製薬株式会社生产的米诺膦酸片（商品名：Bonoteo，规格：1mg/片）为参比制剂，以安徽博诺美科生物医药有限公司提供的米诺膦酸片（规格：1mg/片）为受试制剂，采用随机、开放、单剂量、四周期、完全重复交叉设计，比较受试者空腹状态下服用受试制剂与参比制剂后米诺膦酸的吸收速度与程度，考察关键药动学参数的个体内变异度，为正式试验样本量确定及试验方案优化提供依据。次要研究目的：观察中国健康受试者口服受试制剂米诺膦酸片（规格：1mg/片）和参比制剂米诺膦酸片（商品名：Bonoteo，规格：1mg/片）的安全性。

[Translation]

Main research purpose: Use minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) produced by Aisuo Biotech Co., Ltd. as the reference preparation, and use minodronic acid provided by Anhui Bonomeco Biopharmaceutical Co., Ltd. The tablet (specification: 1 mg/tablet) is the test preparation. A randomized, open-label, single-dose, four-cycle, fully repeated crossover design was adopted to compare the effects of minodronic acid after subjects took the test preparation and the reference preparation in the fasting state. The absorption speed and extent, and the intra-individual variability of key pharmacokinetic parameters are examined to provide a basis for determining the sample size of the formal test and optimizing the test plan. Secondary research purpose: To observe the safety of the test preparation minodronic acid tablets (specification: 1mg/tablet) and the reference preparation minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) orally administered to Chinese healthy subjects sex.

Start Date15 Jul 2024

Sponsor / Collaborator

Anhui Bonomic Biomedical Co., Ltd.

100 Clinical Results associated with Minodronic Acid Hydrate

100 Translational Medicine associated with Minodronic Acid Hydrate

100 Patents (Medical) associated with Minodronic Acid Hydrate

185

Literatures (Medical) associated with Minodronic Acid Hydrate

01 Sep 2024·Current Molecular Medicine

Current Market Potential and Prospects of Copper-based Pyridine Derivatives: A Review

Review

Author: Mishra, Rakhi ; Mazumder, Rupa ; Mazumder, Avijit ; Tyagi, Shivani

Abstract:Nicotine, minodronic acid, nicotinamide (niacin), zolpidem, zolimidine, and other pyridine-based chemicals play vital roles in medicine and biology. Pyridinecontaining drugs are widely available on the market to treat a wide range of human ailments. As a result of these advances, pyridine research is continually expanding, and there are now higher expectations for how it may aid in the treatment of numerous ailments. This evaluation incorporates data acquired from sources, like PubMed, to provide a thorough summary of the approved drugs and bioactivity data for compounds containing pyridine. Most of the reactions discussed in this article will provide readers with a deeper understanding of various pyridine-related examples, which is necessary for the creation of copper catalysis-based synthetic processes that are more accessible, secure, environmentally friendly, and practical, and that also have higher accuracy and selectivity. This paper also discusses significant innovations in the multi-component copper-catalyzed synthesis of N-heterocycles (pyridine), with the aim of developing precise, cost-effective, and environmentally friendly oxygenation and oxidation synthetic methods for the future synthesis of additional novel pyridine base analogs. Therefore, the review article will serve as a novel platform for researchers investigating copperbased pyridine compounds.

01 Aug 2024·Journal of Oral Implantology

Bone Augmentation With Alloplastic Graft Material in a Patient Under Bisphosphonate Therapy: A Case Report and Literature Review

Review

Author: Kuroshima, Shinichiro ; Ichinose, Sosuke ; Ohba, Seigo ; Sawase, Takashi ; Narahara, Shun ; Shido, Rena ; Yamanouch, Yuya ; Yamada, Tomohiro

Cases of relatively safe dental implant treatment in patients with low-volume bisphosphonate (BP) have been gradually reported. Although bone augmentation is commonly used when the bone volume is insufficient for implant placement, the studies and case reports regarding the safety of bone augmentation in patients treated with BP remain insufficient. Herein, we report a case wherein bone augmentation was performed after BP treatment with bone healing realized according to imaging, and we review the literature regarding BP and bone augmentation. A 67-year-old Japanese woman requested implant treatment for a hopeless lower right second molar. She had been taking minodronic acid hydrate (50 mg/4 wk) for 18 months to treat steroid-induced osteoporosis. After obtaining informed consent, tooth extraction and bone augmentation within the extraction socket were performed. The tooth was extracted atraumatically to preserve the surrounding alveolar bone, and the extraction socket was intensely curetted. Subsequently, the socket was filled with carbonate apatite granules and covered with a biodegradable membrane, and the wound was sutured without tension. Although protracted wound healing without any symptoms of infection was observed, the wound healed completely. No clinical symptoms were observed, the color of the mucosa at the site was healthy, and imaging findings at 6 months postoperation indicated that osteogenesis had progressed uneventfully.

01 Jul 2024·International Journal of Surgery Case Reports

A case of successful treatment of medication-related osteonecrosis of the jaw with conservative treatment for pathological mandibular fracture

Article

Author: Ando, Takumi ; Sekido, Katsuhisa ; Hariya, Yasushi ; Harada, Masashi ; Tsuhako, Kota ; Okita, Michiko

INTRODUCTIONSurgical therapy is effective for medication-related osteonecrosis of the jaw. However, appropriate conservative treatment options are still important for cases in which surgery is contraindicated. We report a case of medication-related osteonecrosis of the jaw successfully treated conservatively for a pathological mandibular fracture.PRESENTATION OF CASEAn 84-year-old female patient presented to our department with a chief complaint of inadequate healing of an extraction tooth socket. She had been taking minodronic acid hydrate for approximately five years for osteoporosis. The clinical examination revealed erythema, diffuse swelling of the left mandibular angle, erythema of the buccal gingiva adjacent to the left mandibular first molar, and fistula formation. Although surgery was recommended, the patient declined to proceed. Therefore, a conservative treatment was initiated. A pathological fracture of the inferior mandibular margin was observed one month after the initial visit. Mouth opening was restricted for six months using a bandage. Two months after the pathological fracture, the inferior margin of the fracture was aligned. Five months later, the inferior margin continued. One year later, the bony union of the fracture was observed.DISCUSSIONConservative treatment and restricting mouth opening was effective in our case. Three years and seven months after the pathological fracture, no new sequestrum formation was observed, and the patient was doing well.CONCLUSIONConservative treatment can be effective for medication-related osteonecrosis of the jaw with severe cases.

100 Deals associated with Minodronic Acid Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D09198	Minodronic Acid Hydrate	M05	DB06548

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoporosis	JP	Ono Pharmaceutical Co., Ltd.	21 Jan 2009
Osteoporosis	JP	Astellas Pharma, Inc.	21 Jan 2009
Osteoporosis, Postmenopausal	CN	Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	Phase 3	CN	Jiangsu Ducheng Pharmaceuticals Co., Ltd.	08 Nov 2016
Hypercalcemia	Phase 3	JP	-	-
Multiple Myeloma	Phase 1	JP	-	-
Osteoporosis	Preclinical	-	Ono Pharmaceutical Co., Ltd.	01 Aug 2002
Osteoporosis	Preclinical	-	Astellas Pharma, Inc.	01 Aug 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERA2019	Not Applicable	Maintenance intact parathyroid hormone levels	20	Minodronic Acid	sifryqrxwc(typzuijhpp) = axtwbyyqoh yuuiafmltp (jtqjnoazcc ) View more	Positive	13 Jun 2019
				Control (no minodronic acid)	sifryqrxwc(typzuijhpp) = lhpvfcjqfs yuuiafmltp (jtqjnoazcc )

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