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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
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The pharmacokinetics and bioequivalence of a newly developed extended-released (ER) tablet containing 400 mg pentoxifylline as a test product was compared with the reference brand product Trental® 400 mg ER tablet produced by Sanofi-Aventis. Two separate studies were conducted simultaneously. The first study was conducted under fasting condition, whereas, the second study was conducted under fed condition; using the same batches of the test and reference products in both studies. In each study, both products were administered to 32 healthy male adult volunteers applying a single-dose, two-treatment, two-period, two-sequence, randomized crossover design with one-week washout period between dosing. Twenty two blood samples were withdrawn from each volunteer over 24 hours period.  Pentoxifylline concentrations were determined in plasma by a validated HPLC method according to FDA Bioanalytical Method Validation Guidance using UV detection and chloramphenicol as internal standard. The lower limit of quantitation of the drug in plasma was 5 ng/ml and the upper limit of quantitation was 500 ng/ml. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax,  AUC0-t, AUC0-Â¥, Cmax/AUC0-Â¥, Tmax, lZ & T0.5; were calculated applying non-compartmental analysis. Data of the test and reference products were statistically analyzed to test for bioequivalence of the two products, using criteria of FDA and EMEA Guidance.  The pharmacokinetic parameters mentioned above were statistically analyzed by descriptive statistics, ANOVA test and 90% Confidence Interval (CI). ANOVA test involved the calculation of the effects of: treatment, period, sequence and subjects nested in sequence. According to the above guidance, the primary pharmacokinetic parameters used for bioequivalence testing, namely Cmax, AUC0-t and AUC0-Â¥ were also statistically analyzed by ANOVA & CI tests using the corresponding Ln-transformed values. The mean values  Cmax,  AUC0-t , AUC0-Â¥ , Cmax/AUC0-Â¥ , Tmax, lZ & T0.5 for the test formula obtained from the fasting study  were; 144.4 ng/ml,  845.4 ng.hr/ml, 868.4 ng.hr/ml, 0.186 hr-1, 3.29 hr, 0.561 hr-1 and 1.65 hr, respectively; and the mean values of these parameters for the reference formula were; 150.0 ng/ml,  871.1 ng.hr/ml, 893.7 ng.hr/ml, 0.177 hr-1, 3.70 hr, 0.558 hr-1 and 1.59 hr,  respectively.  The mean values of the above mentioned parameters for the test formula obtained from the fed study were; 157.8 ng/ml, 826.5 ng.hr/ml, 853.8 ng.hr/ml, 0.198 hr-1, 5.4 hr, 0.458 hr-1 and 2.06 hr, respectively; and the mean values of these parameters for the reference formula were; 162.1 ng/ml, 869.7 ng.hr/ml, 894.8 ng.hr/ml, 0.196 hr-1, 4.1 hr, 0.525 hr-1 and 1.80 hr, respectively.  Based on criteria of FDA and   EMEA Guidance on Bioavailability and Bioequivalence, the results of the fasting and fed studies demonstrated bioequivalence of the two products under either condition. Accordingly, it is concluded that the newly developed ER tablet containing 400 mg pentoxifylline is bioequivalent to Trental® 400 mg ER tablet produced by Sanofi-Aventis.

Keywords: Pentoxifylline, Pharmacokinetics, Bioequivalence.

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Publication Date
Sat Dec 01 2018
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Managing risk and its impact in the face of accidents and work injuries in industrial organizations
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The industrial sector of the important drivers of economic activity sectors due to having the capabilities and the potential to qualify biggest contribution to the economic development of the country, which requires the availability of a higher degree of safety in industrial organizations, and the preservation of the lives of employees and workers in emergency situations, and that all the work is not without its dangers, which produces in a year of uncertainty in the possible events get in the future, therefore, reduce the dangers that could be exposed to industrial organizations and management are at the heart of the strategic direction which works to stimulate thinking about the future and respond to the changes that occur in theextern

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Publication Date
Sun Oct 03 2021
Journal Name
Rudn Journal Of Language Studies, Semiotics And Semantics
Motivation of Word Formation in Russian and Arabic Languages and its Role in Achieving Translation Equivalence
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The article is devoted to the issue of word-formation motivation, which does not lose its relevance and plays a role not only in disclosing formal-semantic relations between words of one language and has not only theoretical, but also applied significance. The authors consider word-formation motivation consistently in its varieties in a comparative way on the materials of so different languages as Russian and Arabic and approach the mechanism of achieving semantic equivalence of translation. To the greatest extent, word-formation activity today, due to objective reasons, affects some special branch (technical, medical, etc.) vocabulary, which is increasing from year to year in national dictionaries. This extensive material, selected

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Publication Date
Mon Jan 26 2026
Journal Name
Journal Of Baghdad College Of Dentistry
A Comparative Study of Clinicopathological and Immunohistochemical Expression of CD1a, RANK and RANKL in Langerhans Cell Histiocytosis of Jaw and Skull Lesions
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Background: Langerhans' cell histiocytosis (LCH) is a group of conditions affecting the reticuloendothelial system. It includes Letterer-Siwe disease, Hand-Schuller-Christian disease and eosinophilic granuloma and most often presents in childhood. Materials and methods: Twenty-five cases of LCH were diagnosed histologically and confirmed by CD1a antibody and assessed immunohistochemically using anti-RANKL and anti-RANK antibodies to evaluate osteoclastogenic mechanism. Results: Regarding jaw cases, there was a significant correlation between CD1a and RANK (P=0.016). While in the skull, highly significant correlation existed between RANK and RANKL (p=0.001). Among the sites, there was no statistically significant difference found for each

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Publication Date
Sat Apr 04 2020
Journal Name
Biochemical And Cellular Archives
SYNTHESIS, CHARACTERIZATION AND EVALUATION OF ANTIOXIDANT IN-VIVO AND IN-VITRO AND ANTIBACTERIAL FOR N-(3,4- DIHYDROXYBENZYLIDENE) ACETOHYDRAZONE-2-(BENZYLTHIO) BENZIMIDAZOLE
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Publication Date
Sat Sep 03 2022
Journal Name
International Journal Of Health Sciences
Using Elisa and nested PCR for detection of the toxoplasmosis in milk and the influence of infection and some factors on milk composition in the Iraqi local and Shami goats
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This study concluded detection of Toxoplasma gondii in milk, immunologically by using Elisa and nested PCR)nPCR (based on B1 gene, also to investigate the effect of toxoplasmosis, parity, breed and flock on some milk composition in the Iraqi local and Shami goats in the middle of Iraq. A total of 80 milk samples of the lactating goats were collected. Results of this study showed the prevalence of Toxoplasmosis was 21.25% and 28.75% by Elisa and nPCR respectively without significant differences. The sensitivity of Elisa was a low (30.43%) whereas the specificity was a high (82.45%). The degree of agreement estimated by Kappa coefficient revealed a slight agreement (0.14) between two methods. The results indicated that goats infected

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Publication Date
Tue Jul 12 2016
Journal Name
World Journal Of Experimental Biosciences
Effect of honey and sodium bicarbonate on formation inhibition and removal of Staphylococcus aureus and Klebsiella pneumoniae biofilm in vitro
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Publication Date
Thu Feb 20 2025
Journal Name
Experimental Oncology
The Potential Role of HDAC1 and HDAC3 Immunoexpression in P53 Downregulation and Tumor Aggressiveness of Colon and Rectum Carcinomas Patients
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Background. Colorectal cancer, ranking second place in global cancer mortality, arises from diverse causes. There is growing recognition of the substantial involvement of the epigenetic modifications of histones at the DNA level in the occurrence of CRC. Aim. To assess the expression of p53, HDAC1, and HDAC3 proteins in a cohort of CRC patients and to analyze potential relationship between their expression and the stages of CRC progression. Materials and Methods. The retrospective investigation was carried out on 95 paraffin-embedded CRC tissue samples. The expression of p53, HDAC1, and HDAC3 was assessed immunohistochemically. Results. Notably, the expression of the p53 protein in CRC tissue samples exhibited a prominent correlatio

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Publication Date
Mon Jan 26 2026
Journal Name
Revista Iberoamericana De Psicología Del Ejercicio Y El Deporte, Issn 1886-8576, Vol. 17, Nº. 6, 2022, Págs. 408-412
A Comparative Study In (resilience And Immunity) Psychological And The Level Of Skillful Performance In Some Ball Skills In Rhythmic Gymnastics Between Students Of The Second And Third Stages
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Autorías: Nuha Mohsin Dhahi, Muhammad Hamza Shihab. Localización: Revista iberoamericana de psicología del ejercicio y el deporte. Nº. 6, 2022. Artículo de Revista en Dialnet.

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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
The Importance of Effort and its Impact in Building the Society in the Light of the Holy Book and Sunna
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The Importance of Effort and its Impact in Building the Society in the Light of
the Holy Book and Sunna.
Thank for God and peace be upon Prophet Muhammad, His hose hold and
Companions.
This research is to refute a fault : that Islam as a religioncalls for laziness and
dependence and this in first, Second, to show the originality of the Islamic method in
building and construction.
This research Starts with an introduction in which I refer to the nature of the
Islamic method and its way of work in life: that it is a divine method that is achieved
by the effort of the people them selfves and not through a divine extraordinary power:
The research explains the shift in the peoples life who were addressed by this<

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Publication Date
Fri Sep 01 2023
Journal Name
Iranian Journal Of Veterinary Science And Technology
Investigation of bacterial contamination with Klebsilla and E. coli in the prepucal cavity of pubertal and adult age in caprine
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