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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Jul 01 2018
Journal Name
Journal Of Educational And Psychological Researches
Slums and its implication on security in Baghdad
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The research team seeks to study the phenomena of random housing in Iraqi society in general and Baghdad city in particular by standing on the causes behind this phenomena and its relation with security situation in Baghdad. The researchers adopted a theoretical and practical framework. The main objective is to diagnose the risks caused by the escalation of slums in Baghdad city. 

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Publication Date
Tue Jun 01 2021
Journal Name
Baghdad Science Journal
Physiological and Immunological Disturbance in Rheumatoid Arthritis Patients
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            Rheumatoid arthritis (RA) is a systematic autoimmune disorder with chronic inflammation changes of unknown etiology. Various synovial inflammatory and proliferative alterations may contribute to the cartilaginous tissues and invasive bony tissues, leading to destructive joints and malformed bones. This disease is mostly due to infective microorganisms or genetic susceptibility causing immune system disturbances through triggering both T-cells and B-cells. Furthermore, different immune cells may secret cytokines, which are responsible for some RA pathogenesis activity. From ninety individuals, serum sample was collected; thirty of them were normal and sixty cases were patients with RA attended a privet medical clin

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Publication Date
Thu Jul 01 2021
Journal Name
Journal Of Physics: Conference Series
Compatibility and Edge Spaces in Alpha - Topological Spaces
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Abstract<p>This research presents the concepts of compatibility and edge spaces in <italic>α</italic>-topological spaces, and introduces the <italic>α</italic>-topology combinatorially induced by the <italic>α</italic>-topology. Furthermore, studies the relationship between the <italic>α</italic>-topology on <italic>V</italic> ∪ <italic>E</italic> and the relative <italic>α</italic>-topology on <italic>V</italic>.</p>
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Publication Date
Sat Jun 01 2024
Journal Name
الدراسات اللغوية والرتجمية
PHRASEOLOGY AND ITS ROLE IN THE RUSSIAN LANGUAGE
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Phraseological or phraseological turn - unchanged in structure and composition, integral in meaning and lexically indivisible phrase or sentence, performing the function of a separate dictionary unit - lexemes. Idioms are found in any language of the world. But such a number of winged phrases, as in Russian, is nowhere else. Idioms play a role in displaying the national-cultural characteristics of any language. They very clearly and accurately reflect the characteristics of the perception of the world, the characteristic features of the material and spiritual life of native speakers, his mentality.

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Publication Date
Thu Jun 01 2017
Journal Name
Journal Of The College Of Languages (jcl)
Colonization and Civilization in Aimé Cesaire’s A Tempest
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This study deals with the concepts of Colonialism and Civilization in Aimé Cesaire’s A Tempest. The concern of this study is to discuss how postcolonial writers are continually re-writing the Western canonical works as a reaction to the European cultural hegemony. The Western representations of the black are products of specific moments and developments in history and culture. A Tempest reflects a certain historical moment in the decolonization process.

A Tempest is analysed to reveal the counter literary strategy used by Aimé Cesaire, and to disclose the reasons why re-writing and writing back are considered as vital and inescapable tasks. Shakespeare’s The Tempest, which deals with the

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Publication Date
Tue Jan 01 2019
Journal Name
Open Access Journal Of Chemistry
Gas Storage and Separation in Metal Organic Frameworks
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Publication Date
Tue Oct 31 2023
Journal Name
College Of Islamic Sciences
The shield And its provisions in Islamic jurisprudence
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Since I live in a society in which violence has become widespread, and killing among its own people flared up till they began to kill under the excuse of taking shelter, in these pages I would like to explain the status of taking shelter in the light of Islamic Law (Sharia), exploring scholars’ opinions in the legitimacy or illegitimacy of this issue according to the legal standards.
And, to acquaint people, and myself in the first place, with the true nature and the gravity of this issue; to expose it to those who are unaware of it; to remind those who are already aware of it. I would refute the fabrications, remove the suspicions which surround it untill it made the forbidden permissible; the wrong right. I would explain to those

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Publication Date
Tue Apr 01 2025
Journal Name
Iop Conference Series: Earth And Environmental Science
Review Article: Iron, Zinc and Boron in Sunflower
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There is a real problem when adding micro elements to the soil as a result of fixation, sedimentation, washing or toxicity, and thus economic loss. The plant needs micro elements in very small quantities that do not burn the leaves or cause poisoning to plants, including iron, zinc and boron, as they are essential elements for growth and completing the plant's life cycle, and increase the plant's resistance to diseases and insects, activate enzymes, and form the chlorophyll molecule, in addition to their role in oxidation and reduction processes and vital processes. The use of fertilizers with their modern technology has made the process of activating seeds or foliar nutrition a matter of interest to researchers as a complementary process t

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Publication Date
Sat Jan 01 2022
Journal Name
International Journal Of Research In Social Sciences &amp; Humanities
knowledge sharing and its role in Organizational excellence
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The current research aims to diagnose the extent of interest in knowledge sharing and its role in achieving organizational excellence at the level of the Iraqi environment Primary data through descriptive statistics (arithmetic mean, standard deviation, coefficient of variation, percentages, frequencies) and hypothesis testing using appropriate statistical methods for inferential statistical analysis (Pearson correlation coefficient, simple linear regression, multiple regression, path analysis) and checking the quality of the data from During (normal distribution, confirmatory factor analysis, structural modeling method, and exploratory factor analysis), after collecting data from (358) observations from the company’s leaders, as

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Publication Date
Thu Jun 18 2020
Journal Name
Rimak International Journal Of Humanities And Social Sciences
STRESS IN ENGLISH AND ARABIC: A CONTRASTIVE STUDY
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DBN Rashid, Rimak International Journal of Humanities and Social Sciences, 2020

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