A randomized, open-label, parallel-group, single-dose comparative pharmacokinetics study of a candidate biosimilar WT-1 Trastuzumab with reference product in healthy male subjects

开始日期2025-03-31

申办/合作机构

Chulabhorn Research Institute

TCTR20221104005

/ Completed临床1期

Comparative pharmacokinetics of crude powder, aqueous, and ethanolic extracts of Andrographis paniculata in Thai healthy volunteers under fed condition

开始日期2022-11-11

申办/合作机构

Chulabhorn Research Institute

TCTR20210326007

/ Completed临床2/3期

Evaluation of safety and efficacy of topical longan cream for pain relief associated with osteoarthritis of knee (symptomatic treatment of pain)

开始日期2021-05-03

申办/合作机构

Chulabhorn Research Institute

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项与 Chulabhorn Research Institute 相关的文献（医药）

2025-12-31·PHARMACEUTICAL BIOLOGY

Non-linear oral bioavailability and clinical pharmacokinetics of high-dose Andrographis paniculata ethanolic extract: relevant dosage implications for COVID-19 treatment

Article

作者: Rangkadilok, Nuchanart ; Puranajoti, Porranee ; Songvut, Phanit ; Panomvana, Duangchit ; Akanimanee, Jaratluck ; Suriyo, Tawit ; Satayavivad, Jutamaad ; Pholphana, Nanthanit

AIM:

Insufficient quality control and limited dissolution of Andrographis paniculata extract capsules restricts their bioavailability and hinder the clinical use for treating mild coronavirus disease 2019 (COVID-19) patients.

OBJECTIVE:

This study aims to investigate pharmacokinetics and safety of high-dosage A. paniculata ethanolic extract (equivalent to 180 or 360 mg/day of andrographolide), relevant dosages used for mild COVID-19 treatment.

METHODS:

An open-label, single-dose, and repeated-dose conducted in healthy volunteers. Subjects received capsules containing ethanolic extract equivalent to andrographolide dosage of either 60 or 120 mg per dose, taken every eight hours daily (totaling 180 or 360 mg/day). Safety was assessed through blood chemical analysis and adverse event monitoring after 7 days of ethanolic extract administration.

RESULTS:

Pharmacokinetics of ethanolic extract indicated low plasma levels of the major diterpenoids. The maximum plasma concentration (Cmax) of andrographolide did not exhibit a dose-proportional increase, reaching 6.44 and 11.62 µg/L for single and repeated doses of 60 mg/day, respectively. Doubling the dose (120 mg/day) only resulted in slightly higher Cmax (6.97 and 15.03 µg/L for single and repeated doses, respectively). Safety evaluation revealed mild, transient adverse events, but all parameters remained within normal ranges.

CONCLUSIONS:

This study highlights limitations in the pharmacokinetics of the ethanolic extract of A. paniculata. It indicated non-linear proportionality in the oral bioavailability of andrographolide. These findings suggest that current extraction process of ethanolic extract may hinder its effectiveness. Further research is warranted to explore alternative extraction methods or formulation developments that can enhance the bioavailability of andrographolide and its potential therapeutic effects for COVID-19 treatment.

2025-05-01·JOURNAL OF HAZARDOUS MATERIALS

Estrogenic and anti-estrogenic assessment of the flame retardant, 2-ethylhexyl diphenyl phosphate (EHDPP), and its metabolites: Evidence from in vitro, in silico, and transcriptome studies

Article

作者: Duangta, Sornsawan ; Sangsuwan, Rapeepat ; Ruchirawat, Somsak ; Ruchirawat, Mathuros ; Navasumrit, Panida ; Tachachartvanich, Phum

2-Ethylhexyl diphenyl phosphate (EHDPP) is a replacement flame-retardant commonly found in several environmental matrices and human biospecimens. Although some adverse effects of EHDPP have been identified, the endocrine-disrupting effects of EHDPP and its key metabolites on the human estrogen receptor (ER) are largely unknown. Herein, we report for the first time that EHDPP, at concentrations found in the environment and humans, significantly promoted estrogenic activity and synergized with 17β-estradiol-induced ER transactivation. However, two major EHDPP metabolites 2-ethyl-3-hydroxyhexyl diphenyl phosphate (3-OH-EHDPP) and 2-ethyl-5-hydroxyhexyl diphenyl phosphate (5-OH-EHDPP), inhibited the ER through a non-competitive binding mechanism. Molecular docking showed that Pi-Pi stacking, hydrogen, and hydrophobic bonds primarily stabilize intermolecular interactions between EHDPP and the binding pockets of human ERα and ERβ. Moreover, transcriptome analysis confirmed the estrogenic effects of EHDPP, revealing notable enrichments in ER-mediated signaling and breast cancer pathways, consistent with the validated estrogenic gene expression profile. Intriguingly, EHDPP markedly promoted the clonogenic growth of two ER+ breast cancer cell lines, corroborating the expression levels of ERα protein. Our findings indicate that the common flame-retardant EHDPP activates the ER and downstream signaling, providing far-reaching implications for environmental and health risks associated with estrogen-related adversities such as the development of ER+ breast cancer.

2025-04-01·CHEMICO-BIOLOGICAL INTERACTIONS

Genotoxicity and fibrosis in human hepatocytes in vitro from exposure to low doses of PBDE-47, arsenic, or both chemicals

Article

作者: Ruchirawat, Mathuros ; Chaisatra, Krittinee ; Waraprasit, Somchamai ; Jirasit, Chonnikarn ; Chompoobut, Chalida ; Parnlob, Varabhorn ; Navasumrit, Panida

Improper disposal and recycling of electronic waste (e-waste) has been shown to cause extensive environmental pollution and human health effects. Among the pollutants, 2,2',4,4' Tetrabromodiphenyl Ether (PBDE-47) and arsenic are highly prevalent. This study aimed to investigate genotoxic and fibrosis effects, and their mechanistic relationships from exposure to PBDE-47, arsenic, or both chemicals in a human hepatocyte epithelial cell line (THLE-2). Non-cytotoxic concentrations of 5 μM PBDE-47 (2848 ppb), 0.5 μM arsenite (37.46 ppb), or co-exposure to both were selected and cells were exposed for 7 days. The co-exposure increased the effect of lipid peroxidation (MDA and 4-HNE) and the expression of inflammatory genes (CXCL6, CXCL8, and TGF-β1) over that of PBDE-47 or arsenite alone. Furthermore, the co-exposure significantly increased the level of mutagenic DNA adducts including MDA-derived DNA adducts (Pyrimido[1,2-a]purin-10(3H)-one, M1dG), 8-hydroxydeoxyguanosine (8-OHdG) and 8-nitroguanine; but decreased mRNA expression of an antioxidant defense regulator (NFE2L2) and DNA repair genes (hOGG1 and XRCC1). Regarding biological effects, the co-exposure increased cell migration, a hallmark of epithelial-mesenchymal transition (EMT); down-regulated the epithelial expression (E-cadherin); up-regulated mesenchymal expression (Vimentin); and promoted fibrosis expression (up-regulated ACTA2, FSP-1, and COL1A1). Collectively, these findings indicate that the co-exposure significantly induced a cascade of toxicological effects of overexposure to individual chemicals. The observed genotoxicity, abnormal gene expression, and fibrosis in hepatocytes indicate mechanisms and potentially further increase of health hazards than currently recognized in populations exposed to e-waste chemicals.

项与 Chulabhorn Research Institute 相关的新闻（医药）

2023-02-20

·Healthcare IT News

Latest digital hospital in Thailand taps Ascom for clinical comms

Ascom has been chosen to provide its clinical communications and collaboration solutions to a new medical facility run by the Chulabhorn Hospital in Thailand. Through its Thai partner Xovic, Ascom will deliver an IT ecosystem at the 449-bed Bhadra Maha Rajanusorn Medical Centre, including its mobility devices, a software suite, the Telligence nurse call system, and integration with third-party vendors. The new hospital started operating its emergency department on 9 January. WHY IT MATTERS As part of its digitalisation journey, Chulabhorn Hospital is setting up a digital hospital that has all health data collected from physical devices interfaced with its HIS. It also seeks to use health and hospital information, along with modern technologies, to allow its staff to focus on care, as well as harness data for research. In this regard, Ascom was chosen as its platform enables access, sharing, and tracking of information across the clinical team. Chulabhorn Hospital expects that Ascom's suite of clinical solutions will "provide a new experience" to patients at the new Bhadra Maha Rajanusorn Medical Centre. The Ascom Digistat software, for example, will enable clinical decision support, medical device integration, and alarm management. Additionally, the Ascom Unite software is expected to facilitate communication and collaboration among team members through RTLS and EMR. THE LARGER TREND Ascom continues its expansion across Asia with this latest contract win. Last year, it was tapped by Mahsa University in Malaysia to install the Digistat and Unite systems at its upcoming 400-bed specialist hospital. The health IT provider was also able to bag a multi-million dollar contract to deploy the Telligence nurse call system at an unnamed hospital in Macao. It was also contracted to deliver the same nurse call system to two Mayapada Healthcare hospitals in Indonesia. ON THE RECORD "The deployment at Bhadra Maha Rajanusorn Medical Centre reinforces the power of Ascom Clinical and Collaboration solution enabling clinicians to make informed data-driven decisions," commented Siao-Loon Then, head of sales at Ascom Asia.

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