[Translation] A randomized, double-blind, multicenter phase II study to evaluate the efficacy and safety of genistein capsule combined with basic treatment versus placebo in the treatment of postmenopausal osteoporosis

探索染料木素胶囊不同剂量组治疗绝经后骨质疏松症的安全性和有效性，为Ⅲ期临床试验提供依据

[Translation]

To explore the safety and efficacy of different doses of genistein capsules in the treatment of postmenopausal osteoporosis and provide a basis for Phase III clinical trials

Start Date24 Aug 2015

Sponsor / Collaborator

Xian Hengtai Herbal Technology Co. Ltd.

[+1]

CTR20170330 / CompletedPhase 1

染料木素胶囊在健康受试者的Ⅰ期临床多次给药药代动力学试验

[Translation] Phase I clinical multiple-dose pharmacokinetic study of genistein capsules in healthy subjects

研究染料木素胶囊在健康受试者的多次给药药代动力学，为Ⅱ期临床试验用药方案的制定提供科学依据。

[Translation]

The pharmacokinetics of genistein capsules after multiple doses in healthy subjects were studied to provide a scientific basis for the formulation of medication regimens for Phase II clinical trials.

Start Date06 Nov 2006

Sponsor / Collaborator

Xian Hengtai Herbal Technology Co. Ltd.

[+1]

CTR20170329 / CompletedPhase 1

染料木素胶囊在健康受试者的Ⅰ期临床单次给药药代动力学试验

[Translation] Phase I clinical single-dose pharmacokinetic study of genistein capsules in healthy volunteers

研究染料木素胶囊在健康受试者的单剂量人体药代动力学和在进食状态下的药动学以观察食物对药物吸收的影响，为Ⅱ期临床试验用药方案的制定及临床合理化用药提供科学依据。

[Translation]

The single-dose human pharmacokinetics of genistein capsules in healthy subjects and the pharmacokinetics in the fed state were studied to observe the effect of food on drug absorption, so as to provide a scientific basis for the formulation of the medication plan for Phase II clinical trials and the rational use of drugs in clinical practice.

Start Date01 Jun 2006

Sponsor / Collaborator

Xian Hengtai Herbal Technology Co. Ltd.

[+1]

100 Clinical Results associated with Genistein Capsule

100 Translational Medicine associated with Genistein Capsule

100 Patents (Medical) associated with Genistein Capsule

Literatures (Medical) associated with Genistein Capsule

01 Nov 2023·European Journal of Hospital PharmacyQ4 · MEDICINE

Paediatric capsule compounding in hospital practices: by weight or by volume?

Q4 · MEDICINE

Article

Author: Vanelle, Patrice ; Curti, Christophe ; Bouguergour, Cyrielle ; Primas, Nicolas ; Panuccio, Camille ; Wasilewski, Maya ; Thevin, Patrick ; Lamy, Edouard

OBJECTIVECapsule compounding is common for paediatric patients. In Europe, pharmacists often use a volume-based method whereas, in the USA, the weight-based method prevails. These two methods should be compared in order to help hospital pharmacists to make their choice.METHODSWe evaluated the difference between the volume-based method and the weight-based method with 10 mg spironolactone capsules. Six independent batches were made with each technique and their conformity was evaluated with a high-performance liquid chromatography assay.RESULTSThe weight-based method showed superiority over the volume-based method for the following parameters: spironolactone content homogeneity, total weight content homogeneity, batch reproducibility and batch conformity. No differences were seen in spironolactone content between the two methods, but an overall trend towards underweighing the excipient was found with the volume-based method.CONCLUSIONSCapsule compounding with the weight-based method increases the quality of the resulting formulation. The weight-based method requires knowledge of the galenic parameters of the active pharmaceutical ingredient and excipients, but should be preferred to the volume-based method.

25 Nov 2022·Medicine

Efficacy and safety of Yaobitong capsule for acute lumbar disc herniation: A protocol for a multi-center randomized controlled trial

Article

Author: Tang, Bin ; Yin, He ; Lei, Qunhui ; Zhou, Guohui ; Wang, Siyi ; Zhang, Xianshuai ; Zhao, Changwei ; Yang, Kexin ; Shi, Mingpeng ; Li, Shaojun ; Li, Zhenhua ; Gu, Mingyu

Background:There are few effective conservative therapies for acute lumbar disc herniation (LDH), and the choice of nonsteroidal anti-inflammatory drugs is not recommended for all patients. The purpose of this study was to compare the effect of Yaobitong capsule with celecoxib capsule, and to further confirm the safety and efficacy of Yaobitong capsule.Methods:This study is a large sample multicenter randomized controlled trial. Eight hospitals served as sub centers to recruit patients. A total of 258 patients are divided into Yaobitong group and celecoxib group according to the ratio of 1:1. Celecoxib or Yaobitong capsule was taken orally for 14 days. Patients will complete the trial after 3 months of follow-up, and independent statisticians who are blinded to random assignment will analyze the data using SAS 9.3 software. The primary outcome was the visual analogue scale (VAS) score after 14 days of treatment, and Japanese Orthopaedic Association (JOA), Oswestry Disability Index (ODI), and SF-12 will be regarded as secondary outcomes. Safety indexes will be recorded before and after treatment, and adverse events (AEs) will be recorded throughout this trial.Discussion:This study will evaluate the efficacy and safety of Yaobitong capsule in treating LDH. The experimental results will provide evidence support to treat LDH with Yaobitong capsule.

12 Mar 2021·Journal of Antimicrobial ChemotherapyQ2 · MEDICINE

Drug–drug interaction between itraconazole capsule and efavirenz in adults with HIV for talaromycosis treatment

Q2 · MEDICINE

Article

Author: Chaiwarith, Romanee ; Sirisanthana, Thira ; Kaewpoowat, Quanhathai ; Cressey, Tim R ; Yasri, Saowaluck ; Chindamporn, Ariya ; Worasilchai, Navaporn

AbstractObjectivesTo assess the pharmacokinetic of itraconazole capsule formulation and its active metabolite, hydroxyitraconazole, in adults with HIV diagnosed with talaromycosis in an endemic area, and to evaluate the drug–drug interaction between itraconazole/hydroxyitraconazole (ITC/OH-ITC) and efavirenz.MethodsOpen-label, single arm, sequential pharmacokinetic study. Eligible subjects were adults with HIV, ≥18 years old, with confirmed talaromycosis, initiating itraconazole capsule as part of standard talaromycosis treatment, in whom efavirenz-based ART was anticipated. Steady-state pharmacokinetic assessments (pre-dose and at 1, 3, 4, 5, 6, 8 and 12 h post dose) were performed for itraconazole/hydroxyitraconazole without and with efavirenz use. Mid-dose efavirenz concentrations were also assessed. Pharmacokinetics parameters were calculated using non-compartmental analysis.ResultsTen subjects (70% male) were enrolled. At entry, median (range) age was 29.5 years (22–64), and CD4 cell count was 18.0 (1–39) cells/mm3. Geometric mean (95% CI) of itraconazole and hydroxyitraconazole AUC0–12 without efavirenz were 9097 (6761–12 239) and 11 705 (8586-15 959) ng·h/mL, respectively, with a median metabolic ratio of OH-ITC : ITC of 1.3 (95% CI 0.9–1.9). Intra-subject comparison revealed that both itraconazole and hydroxyitraconazole exposures were significantly reduced with concomitant efavirenz use, with the mean AUC0–12 of itraconazole and hydroxyitraconazole being 86% (71%–94%) and 84% (64%–97%) lower, respectively. With efavirenz, itraconazole trough concentrations were also below the recommended therapeutic level (0.5 μg/mL). All subjects had mid-dose efavirenz concentrations >1000 ng/mL.ConclusionsConcomitant administration of itraconazole capsule with efavirenz significantly reduced itraconazole and hydroxyitraconazole exposures. The clinical impact of this drug–drug interaction on talaromycosis treatment or prophylaxis in the era of potent ART needs further evaluation.

100 Deals associated with Genistein Capsule

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis	Phase 2	CN	Institute of Materia Medica, Fourth Military Medical University of the Chinese People's Liberation Army	24 Aug 2015
Osteoporosis	Phase 2	CN	Xian Hengtai Herbal Technology Co. Ltd.	24 Aug 2015

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