Bioequivalence Study of Clopidogrel 75 Mg Tablets in Healthy Male Volunteers

Zou, Jian- Jun; Tan, Jie; Fan, Hongwei

doi:10.4172/jbb.1000102

Cited by 5 publications

(2 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The cells were subsequently incubated with increasing concentrations (1 × C max , 2 × C max , 4 × C max , 8 × C , max and 10 × C max ) of Anastrozole alone (Ana), Anastrozole + Aspirin + Clopidogrel (AnaAspClop), Anastrozole + Atopaxar (AnaAto), Aspirin + Clopidogrel (AspClop), and Atopaxar (Ato) in appropriate culture media for 24 h. The drug concentrations were derived from the C max concentrations; Anastrozole 16.16 ng/mL (Product monograph, 2013), Aspirin 4.4 µg/mL (Voelker & Hammer, 2012), Clopidogrel bisulfate 1.86 ng/mL (Zou et al, 2012), and inhibitory concentration for Atopaxar hydrobromide 0.064 µM (Kogushi et al, 2011). The diluent controls were prepared by exposing cells to 0.03%DMSO (corresponding to the final percentage of DMSO in working solutions) for 24 h.…”

Section: Methodsmentioning

confidence: 99%

Combined Anastrozole and Antiplatelet Therapy Treatment Differentially Promotes Breast Cancer Cell Survival

2020

View full text Add to dashboard Cite

Thromboembolic disorders are the second leading cause of death in breast cancer. Antiplatelet therapy combined with cancer therapy is a potential treatment strategy against cancer-associated thromboembolic disorders; however, the efficacy of such dual treatment has not been established. This study reports novel findings on the response of hormone-dependent breast cancer cell lines (MCF7/T47D) following 24 h treatment with Anastrozole, combined with Aspirin and Clopidogrel cocktail; and Atopaxar. Neutral red and lactate dehydrogenase assays were conducted to assess viability and cytotoxicity respectively. Flow cytometric Annexin-V/PI assay was used to assess the mode of cell death. Morphological alterations were studied using scanning electron microscopy. Statistical analysis was conducted using Statistica V13. Definitive outcomes were established with flow cytometric detection of phosphatidylserine exposure and propidium iodide staining, complemented with ultrastructural analysis. Results showed that a few cells were undergoing death mainly through secondary necrosis. Morphological features suggesting induced cell motility (pseudopodia/ruffled membranes) were observed in both cell lines; notably, T47D cells presented pronounced features than MCF7 cells. Overall, these findings suggest that such combined treatment may differentially promote cell survival, inducing a more aggressive breast cancer phenotype.

show abstract

Section: Methodsmentioning

confidence: 99%

Combined Anastrozole and Antiplatelet Therapy Treatment Differentially Promotes Breast Cancer Cell Survival

2020

View full text Add to dashboard Cite

show abstract

“…For experimentation, MCF7 and T47D cells were seeded at 1 × 10 5 /well in a 24-well plate. Cells were treated with Cmax concentrations of 16.16 ng/mL anastrozole [77] (Sigma-Aldrich, Kempton Park, South Africa, A2736), 4.4µg/mL aspirin [94] (Sigma-Aldrich, A2093), 1.86ng/mL clopidogrel bisulphate [95] (Sigma-Aldrich, PHR1431), and 0.064 µM atopaxar hydrobromide [89] (Axon Medchem, Groningen, The Netherlands, 2030) for 24 h. Controls included a culture-media-only control and a diluent control corresponding to the final percentage of DMSO (0.03% DMSO) in working solutions. For experimentation, 300 µL whole blood (WB) were exposed to treated breast cancer cells for 5 min at room temperature (20-25 • C) [60,67].…”

Section: Experimentationmentioning

confidence: 99%

Antiplatelet Therapy Combined with Anastrozole Induces Features of Partial EMT in Breast Cancer Cells and Fails to Mitigate Breast-Cancer Induced Hypercoagulation

Xulu

Augustine

2021

IJMS

View full text Add to dashboard Cite

Thromboembolic complications are a leading cause of morbidity and mortality in cancer patients. Cancer patients often present with an increased risk for thrombosis including hypercoagulation, so the application of antiplatelet strategies to oncology warrants further investigation. This study investigated the effects of anastrozole and antiplatelet therapy (aspirin/clopidogrel cocktail or atopaxar) treatment on the tumour responses of luminal phenotype breast cancer cells and induced hypercoagulation. Ethical clearance was obtained (M150263). Blood was co-cultured with breast cancer cell lines (MCF7 and T47D) pre-treated with anastrozole and/or antiplatelet drugs for 24 h. Hypercoagulation was indicated by thrombin production and platelet activation (morphological and molecular). Gene expression associated with the epithelial-to-mesenchymal transition (EMT) was assessed in breast cancer cells, and secreted cytokines associated with tumour progression were evaluated. Data were analysed with the PAST3 software. Our findings showed that antiplatelet therapies (aspirin/clopidogrel cocktail and atopaxar) combined with anastrozole failed to prevent hypercoagulation and induced evidence of a partial EMT. Differences in tumour responses that modulate tumour aggression were noted between breast cancer cell lines, and this may be an important consideration in the clinical management of subphenotypes of luminal phenotype breast cancer. Further investigation is needed before this treatment modality (combined hormone and antiplatelet therapy) can be considered for managing tumour associated-thromboembolic disorder.

show abstract

Comparative Bioequivalence Study of 2 Clopidogrel 75‐mg Tablet Formulations in Moroccan Volunteers

Orche,

Khabbaz,

Cheikh

et al. 2024

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

This study investigates the pharmacokinetic properties and bioequivalence of 2 formulations of clopidogrel tablets administered to a cohort of healthy Moroccan male volunteers. The primary objective was to assess the rate and extent of drug absorption from the test formulation in comparison to a reference formulation, focusing on critical parameters including maximum plasma concentration (Cmax), area under the concentration‐time curve from 0 to the last measurable time (AUC0‐t), and area under the concentration‐time curve extrapolated to infinity (AUC0‐∞). The results revealed that the geometric mean ratios of Cmax, AUC0‐t, and AUC0–∞ for the test formulation relative to the reference formulation were 105.7%, 105.6%, and 105.6%, respectively. The 90% confidence intervals for these parameters fell within the predefined bioequivalence range of 80%‐125%, indicating a statistically and clinically equivalent performance between the 2 formulations. This investigation sheds light on the pharmacokinetic behavior of clopidogrel in the context of the Moroccan male population, offering valuable insights into the comparability of formulations.

show abstract

Bioequivalence Study of Clopidogrel 75 Mg Tablets in Healthy Male Volunteers

Cited by 5 publications

References 17 publications

Combined Anastrozole and Antiplatelet Therapy Treatment Differentially Promotes Breast Cancer Cell Survival

Combined Anastrozole and Antiplatelet Therapy Treatment Differentially Promotes Breast Cancer Cell Survival

Antiplatelet Therapy Combined with Anastrozole Induces Features of Partial EMT in Breast Cancer Cells and Fails to Mitigate Breast-Cancer Induced Hypercoagulation

Comparative Bioequivalence Study of 2 Clopidogrel 75‐mg Tablet Formulations in Moroccan Volunteers

Contact Info

Product

Resources

About