[Translation] A randomized, open-label, single-dose, crossover bioequivalence study of dronedarone hydrochloride tablets (400 mg) in healthy Chinese subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Sanofi Aventis U.S., LLC为持证商的盐酸决奈达隆片（商品名：迈达龙®，规格：400mg）为参比制剂，对安徽艾立德制药有限公司生产、江苏艾立康医药科技有限公司提供的受试制剂盐酸决奈达隆片（规格：400mg）进行空腹和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，比较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盐酸决奈达隆片（规格：400mg）和参比制剂盐酸决奈达隆片（商品名：迈达龙®，规格：400mg）的安全性。

[Translation]

Main study purpose: According to the relevant provisions of bioequivalence test, dronedarone hydrochloride tablets (trade name: Maidalong®, specification: 400mg) of which Sanofi Aventis U.S., LLC is the licensee was selected as the reference preparation, and the test preparation dronedarone hydrochloride tablets (specification: 400mg) produced by Anhui Aili Pharmaceutical Co., Ltd. and provided by Jiangsu Ailikang Pharmaceutical Technology Co., Ltd. were subjected to human bioequivalence test for fasting and postprandial administration, 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 compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation dronedarone hydrochloride tablets (specification: 400mg) and the reference preparation dronedarone hydrochloride tablets (trade name: Maidalong®, specification: 400mg) in healthy subjects.

Start Date09 Aug 2024

Sponsor / Collaborator

Anhui Ailide Pharmaceutical Co., Ltd.Startup

CTR20233185

/ CompletedNot Applicable

盐酸决奈达隆片（400mg）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、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dronedarone hydrochloride tablets (400 mg) in healthy Chinese subjects after meal administration

主要研究目的：按有关生物等效性试验的规定，选择Sanofi Aventis U.S.,LLC为持证商的盐酸决奈达隆片（商品名：迈达龙，规格：400mg）为参比制剂，对石家庄四药有限公司生产的受试制剂盐酸决奈达隆片（规格：400mg）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：观察健康志愿受试者口服受试制剂盐酸决奈达隆片（规格：400mg）和参比制剂盐酸决奈达隆片（商品名：迈达龙，规格：400mg）的安全性。

[Translation]

The main purpose of the study: According to the relevant provisions of the bioequivalence test, the dronedarone hydrochloride tablets (trade name: Maidalong, specification: 400mg) of Sanofi Aventis U.S., LLC as the licensee were selected as the reference preparation, and the human bioequivalence test of the test preparation dronedarone hydrochloride tablets (specification: 400mg) produced by Shijiazhuang Siyao Co., Ltd. was conducted 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 the condition of postprandial administration. The secondary purpose of the study: To observe the safety of the test preparation dronedarone hydrochloride tablets (specification: 400mg) and the reference preparation dronedarone hydrochloride tablets (trade name: Maidalong, specification: 400mg) taken orally by healthy volunteers.

Start Date19 Nov 2023

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20233468

/ CompletedNot Applicable

盐酸决奈达隆片的人体生物等效性研究

[Translation] Study on the bioequivalence of dronedarone hydrochloride tablets in healthy volunteers

研究空腹/餐后状态下单次口服受试制剂盐酸决奈达隆片与参比制剂盐酸决奈达隆片（迈达龙®）在健康成年男性受试者体内的药代动力学，评价空腹/餐后状态下口服两种制剂的生物等效性和安全性。

[Translation]

To study the pharmacokinetics of a single oral dose of the test preparation dronedarone hydrochloride tablets and the reference preparation dronedarone hydrochloride tablets (Meidalong®) in healthy adult male subjects in the fasting/postprandial state, and to evaluate the bioequivalence and safety of the two preparations in the fasting/postprandial state.

Start Date25 Oct 2023

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with VDCCs x α-adrenergic receptor

100 Translational Medicine associated with VDCCs x α-adrenergic receptor

0 Patents (Medical) associated with VDCCs x α-adrenergic receptor

114

Literatures (Medical) associated with VDCCs x α-adrenergic receptor

01 Feb 2025·American Journal of Hematology

Blood Plasma Methylated DNA Markers in the Detection of Lymphoma: Discovery, Validation, and Clinical Pilot

Article

Author: Katerov, Slava ; Graham, Rondell P. ; Novak, Anne J. ; Jevremovic, Dragan ; Burger, Kelli N. ; Berger, Calise K. ; Mahoney, Douglas W. ; O'Connell, Maria C. ; Taylor, William R. ; Cerhan, James R. ; Witzig, Thomas E. ; Allawi, Hatim T. ; Dao, Linda N. ; Doering, Karen A. ; Bamlet, William R. ; Hennek, Jacquelyn ; Foote, Patrick H. ; Kisiel, John B. ; Devens, Mary E. ; Arndt, Jacquelyn R.

ABSTRACTLymphoma is one of the leading causes of cancer and cancer deaths and yet has not been amenable to population screening. The role of methylated DNA markers (MDMs) in the detection of lymphoma has not been extensively studied. We aimed to discover, validate, and test tissue–derived MDMs of lymphoma in archival plasma specimens. Reduced representation bisulfite sequencing (RRBS) was performed on a discovery set of frozen tissues. MDMs identified were converted to methylation–specific PCR assays and validated on independent formalin–fixed, paraffin‐embedded (FFPE) tissues. Target enrichment long–probe quantitative‐amplified signal (TELQAS) assays were developed and assayed in plasma–extracted, bisulfite‐converted DNA from independent treatment‐naïve lymphoma patients and healthy controls. Prediction of cancer status was modeled using random forest model with in silico cross‐validation. After discovery and validation in tissue, 16 TELQAS assays (ZNF503, VWA5B1, HOXA9, GABRG3, ITGA5, MAX.chr17.7190, BNC1, CDK20, MAX.chr4.4069, TPBG, DNAH14, SYT6, CACNG8, FAM110B, ADRA1D, and NRN1) were selected for testing in plasma. These detected 78% (95% CI, 74%–82%) of lymphoma cases at 90% specificity. Excluding marginal zone and T‐cell lymphomas, sensitivity increased to 84% (80%–88%). MDMs in plasma show promise to detect lymphoma and are candidates for inclusion in multi‐cancer detection studies.

01 Apr 2024·Heliyon

Identification of a de novo CACNA1B variant and a start-loss ADRA2B variant in paroxysmal kinesigenic dyskinesia

Article

Author: Liu, Yihui ; Liu, Yuxing ; Yuan, Zhuangzhuang ; Wang, Chenyu ; Wang, Qian ; Huang, Hao ; Fan, Liangliang

Paroxysmal kinesigenic dyskinesia (PKD) represents the most prevalent form of paroxysmal dyskinesia, characterized by recurrent and transient attacks of involuntary movements triggered by a sudden voluntary action. In this study, whole-exome sequencing was conducted on a cohort of Chinese patients to identify causal mutations. In one young female case, a de novo CACNA1B variant (NM_000718.3:exon3:c.479C > T:p.S160F) was identified as the causative lesion. This finding may broaden the phenotypic spectrum of CACNA1B mutations and provide a prospective cause of primary PKD. Additionally, a novel start-loss variant (NM_000682.7:c.3G > A) within ADRA2B further denied its association with benign adult familial myoclonic epilepsy, and a KCNQ2 E515D variant that was reported as a genetic susceptibility factor for seizures had no damaging effect in this family. In sum, this study established a correlation between CACNA1B and primary PKD, and found valid evidence that further negates the pathogenic role of ADRA2B in benign adult familial myoclonic epilepsy.

01 Feb 2024·Biochemical and Biophysical Research Communications

Subcellular localization and ER-mediated cytotoxic function of α1A and α1ACT in spinocerebellar ataxia type 6

Article

Author: Honda, Shinya ; Shimizu, Shigeomi ; Mizusawa, Hidehiro ; Shin, Min Kyoung ; Watase, Kei ; Wang, Di ; Ishikawa, Kinya

Spinocerebellar ataxia type 6 (SCA6) is a polyglutamine (polyQ) disease, which is caused by the elongation of CAG repeats encoding polyQ in the CACNA1A gene. The CACNA1A gene encodes two proteins, namely, α1A (a subunit of the plasma membrane calcium channel), which is translated in its entire length, and α1ACT, which is translated from the second cistron, and both proteins have a polyQ tract. The α1A-polyQ and α1ACT-polyQ proteins with an elongated polyQ stretch have been reported to form aggregates in cells and induce neuronal cell death, but the subcellular localization of these proteins and their cytotoxic properties remain unclear. In this study, we first analyzed SCA6 model mice and found that α1A-polyQ^long localized mainly to the Golgi apparatus, whereas a portion of α1ACT-polyQ^long localized to the nucleus. Analysis using Neuro2a cells also showed similar subcellular localizations of these proteins, and a proportion of both proteins localized to the endoplasmic reticulum (ER). Cytotoxic studies demonstrated that both proteins induce both the ER stress response and apoptosis, indicating that they are able to induce ER stress-induced apoptosis.

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