[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.

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 ADRA1 x calcium channel

100 Translational Medicine associated with ADRA1 x calcium channel

0 Patents (Medical) associated with ADRA1 x calcium channel

103

Literatures (Medical) associated with ADRA1 x calcium channel

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. ; Dao, Linda N. ; Doering, Karen A. ; Allawi, Hatim T. ; Kisiel, John B. ; Bamlet, William R. ; Hennek, Jacquelyn ; Foote, Patrick H. ; 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 May 2024·Archives of Biochemistry and Biophysics

Capsaicin induces ATP-dependent thermogenesis via the activation of TRPV1/β3-AR/α1-AR in 3T3-L1 adipocytes and mouse model

Article

Author: Yun, Jong Won ; Abdillah, Alfin Mohammad

Capsaicin (CAP) is a natural bioactive compound in chili pepper that activates the transient receptor potential vanilloid subfamily 1 (TRPV1) and is known to stimulate uncoupling protein 1 (UCP1)-dependent thermogenesis. However, its effect on ATP-dependent thermogenesis remains unknown. In this study, we employed qRT-PCR, immunoblot, staining method, and assay kit to investigate the role of CAP on ATP-dependent thermogenesis and its modulatory roles on the TRPV1, β3-adrenergic receptor (β3-AR), and α1-AR using in vitro and in vivo models. The studies showed that CAP treatment in high-fat diet-induced obese mice resulted in lower body weight gain and elevated ATP-dependent thermogenic effectors' protein and gene expression through ATP-consuming calcium and creatine futile cycles. In both in vitro and in vivo experiments, CAP treatment elevated the protein and gene expressions of sarcoendoplasmic/endoplasmic reticulum calcium ATPase 2 (SERCA2), ryanodine receptor 2 (RYR2), creatine kinase B (CKB), and creatine kinase mitochondrial 2 (CKMT2) mediated by the activation of β3-AR, α1-AR, and TRPV1. Our study showed that CAP increased intracellular Ca²⁺ levels and the expression of voltage-dependent anion channel (VDAC) and mitochondrial calcium uniporter (MCU) which indicates that increased mitochondrial Ca²⁺ levels lead to increased expression of oxidative phosphorylation protein complexes as a result of ATP-futile cycle activation. A mechanistic study in 3T3-L1 adipocytes revealed that CAP induces UCP1- and ATP-dependent thermogenesis mediated by the β3-AR/PKA/p38MAPK/ERK as well as calcium-dependent α1-AR/TRPV1/CaMKII/AMPK/SIRT1 pathway. Taken together, we identified CAP's novel functional and modulatory roles in UCP1- and ATP-dependent thermogenesis, which is important for developing therapeutic strategies for combating obesity and metabolic diseases.

28 Oct 2023·Journal of Microbiology and Biotechnology

Echinacoside Induces UCP1- and ATP-Dependent Thermogenesis in Beige Adipocytes via the Activation of Dopaminergic Receptors

Article

Author: Yun, Jong Won ; Haddish, Kiros

Echinacoside (ECH) is a naturally occurring phenylethanoid glycoside, isolated from Echinacea angustifolia, and this study aimed to analyze its effect on thermogenesis and its interaction with dopaminergic receptors 1 and 5 (DRD1 and DRD5) in 3T3-L1 white adipocytes and mice models. We employed RT-PCR, immunoblot, immunofluorescence, a staining method, and an assay kit to determine its impact. ECH showed a substantial increase in browning signals in vitro and a decrease in adipogenic signals in vivo. Additionally, analysis of the iWAT showed that the key genes involved in beiging, mitochondrial biogenesis, and ATP-dependent thermogenesis were upregulated while adipogenesis and lipogenesis genes were downregulated. OXPHOS complexes, Ca²⁺ signaling proteins as well as intracellular Ca²⁺ levels were also upregulated in 3T3-L1 adipocytes following ECH treatment. This was collectively explained by mechanistic studies which showed that ECH mediated the beiging process via the DRD1/5-cAMP-PKA and subsequent downstream molecules, whereas it co-mediated the α1-AR-signaling thermogenesis via the DRD1/5/SERCA2b/RyR2/CKmt pathway in 3T3-L1 adipocytes. Animal experiments revealed that there was a 12.28% reduction in body weight gain after the ECH treatment for six weeks. The effects of ECH treatment on adipose tissue can offer more insights into the treatment of obesity and metabolic syndrome.

News (Medical) associated with ADRA1 x calcium channel

02 Apr 2025

·www.prnewswire.com

Hanmi Pharmaceutical's 'Gugutams' to be Launched in Mexico as 'Aditams', Marking the Start of Full-Scale Latin America Expansion

Hanmi Pharm Begins Local Sales of Urological Product 'Aditams' in Mexico with Partner 'Laboratorios Silanes' Launch completed in February, Hanmi Pharm's Third Product to Enter Latin America Aditams, The First Urological Combination Drug for OPG and ED Exported to Mexico SEOUL, South Korea, April 2, 2025 /PRNewswire/ -- Hanmi Pharmaceutical's combination therapy for Obstructive Prostatic Growth (OPG) caused by Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED), Gugutams, is entering the Mexican market under the local brand name "Aditams." Continue Reading Aditams Hanmi Pharmaceutical announced that it has completed the launch of Aditams in Mexico under the export agreement signed in October 2020 with the Mexican pharmaceutical company 'Laboratorios Silanes'. Under the agreement, Hanmi Pharmaceutical plans to export Gugutams to the Mexican market for a period of seven years, starting in February 2025. Gugutams, developed by Hanmi Pharmaceutical, is the world's first urological combination therapy combining two active ingredients: tamsulosin, a treatment for Obstructive Prostatic Growth (OPG), and tadalafil, a treatment for erectile dysfunction (ED). It is also noteworthy as the first prescription drug in Korea to apply Poly-Cap technology, which integrates multiple active ingredients into a single capsule. Laboratorios Silanes, a leading pharmaceutical company in Mexico founded in 1943, is committed to providing innovative healthcare solutions and driving rapid growth in the industry. It has established itself as a key player in the Latin American pharmaceutical market through its robust distribution network and strategic collaborations with global partners. Silanes previously collaborated with Hanmi Pharmaceutical in 2023 to successfully introduce the hypertension and dyslipidemia combination treatment 'Amosartan Q', under the local brand 'Lodarta' and in 2024 to introduce the combination hypertension treatment 'Amosartan Plus' under the local brand 'Bicartial-CTD'. Following these products, Gugutams, under the local brand 'Aditams', becomes Hanmi Pharmaceutical's third product in the Latin American region. Aditams, as the first urological combination therapy to enter the Mexican market, is expected to offer a new treatment option for patients suffering from both Obstructive Prostatic Growth (OPG) and erectile dysfunction (ED). By managing both conditions with a single medication, it significantly enhances patient convenience and maximizes therapeutic efficacy. Hanmi continues to focus on expanding its partnerships in emerging markets such as the Middle East and Latin America, in addition to its established presence in developed markets like North America and Japan. The company aims to leverage strategic partners like Laboratorios Silanes as key footholds to broaden its product portfolio and regional reach. Park Jae-hyun, CEO of Hanmi Pharmaceutical, stated, "As the first urological combination therapy to enter the Mexican market, Gugutams is expected to present a new treatment paradigm for local patients." He added, "Through this collaboration with Laboratorios Silanes, we aim to solidify Hanmi Pharmaceutical's presence in the Latin American market and leverage this as a foundation to further strengthen our competitiveness in the global pharmaceutical industry." Official Websites: About Hanmi Pharmaceutical: Hanmi Pharmaceutical is an R&D-focused pharmaceutical company committed to developing globally innovative therapies in areas of high unmet medical needs such as obesity/metabolism, oncology, and rare diseases. Hanmi leverages proprietary platform technologies, including long-acting biologics and bispecific antibodies, to address unmet medical needs. The company emphasizes open innovation and has established numerous global partnerships to advance its research and development efforts. SOURCE Hanmi Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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