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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed May 18 2016
Journal Name
Al-academy
Metaphoric assimilation of the place and its total functioning in scenario: إيهاب ياسين طه
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Abstract: The study of the place is hardly a concern for most researchers in the art generally. It is hardly devoid of any movie of some configuration elements that are essential to him about and place one of them, and we find an echo location consists ago to begin screenwriter put Sightseeing begins features emerge there will be functioning simple scenario what would soon receive a growing Cummings final picture film. Metaphoric place begins to emerge in the form of linguistic scenario is soon to be translated in another language, the language of the image. Which in turn complement the creative process of this art and have a significant impact in terms of content and curriculum and installation in and it even to seek the true meaning fu

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Publication Date
Sun Jun 30 2013
Journal Name
Al-khwarizmi Engineering Journal
Effect of Solid Particle Properties on Heat Transfer and Pressure Drop in Packed Duct
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This work examines numerically the effects of particle size, particle thermal conductivity and inlet velocity of forced convection heat transfer in uniformly heated packed duct. Four packing material (Aluminum, Alumina, Glass and Nylon) with range of thermal conductivity (from200 W/m.K for Aluminum to 0.23 W/m.K for Nylon), four particle diameters (1, 3, 5 and 7 cm), inlet velocity ( 0.07, 0.19 and 0.32 m/s) and constant heat flux ( 1000, 2000 and 3000 W/ m 2) were investigated. Results showed that heat transfer (average Nusselt number Nuav) increased with increasing packing conductivity; inlet velocity and heat flux, but decreased with increasing particle size.Also, Aluminum average Nusselt number is about (0.85,2.

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Publication Date
Wed Mar 27 2013
Journal Name
Engineering And Technology Journal
Total and Matric Suction in Unsaturated Soil with the Existence of Different Salts Content
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Publication Date
Wed Jun 03 2020
Journal Name
Political Sciences Journal
The presidential system in Turkey between reality and challenges: a vision of the future
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The nature of the political system of any country in the international system must have an impact on the policy of the State, whether in the interior or exterior, both regional and international, Turkey is one of the most important countries in the Middle East, which have a place and effectiveness on the surrounding environment, hence the importance of research lies in its political system and the transfer of power in it and its transformation from the form of the parliamentary system to the presidential system of the repercussions of the task and mutual effects between Turkey and the countries of the surrounding region in terms of the extent of achieving political stability in the Turkish interior or not and how this can be refl

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Publication Date
Sun Jul 03 2011
Journal Name
Journal Of Educational And Psychological Researches
Educational activities in the role of government nurseries and its relationship to some variables
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The skill of management educational activities gradually grow with the experience, but they differ from personal skill educator to another, because each style nanny personally and the way to work. There educator and active movement and vitality that look like happiness and clear during the implementation of the activity, and the other runs educational activities quietly, efficiently and without emotion and clear (dry, 2001: p. 274). And the stage of childhood is one of the most important stages that are based upon the future life as a whole because the man also confirmed by the School of analysis psychological is the son of his childhood and the best example to us what the Holy Prophet Muhammad (peace be upon him): (Every child i

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Publication Date
Mon Dec 25 2000
Journal Name
Journal Of Advanced Research In Fluid Mechanics And Thermal Sciences
Enhancement of nanofluid heat transfer in elliptical pipe and helical micro tube heat exchanger
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Publication Date
Sun Oct 18 2020
Journal Name
Al-kindy College Medical Journal
Management of COVID-19 in Children and Adolescents -A Practical Up-to Date Guideline
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Sufficient high-quality data are unavailable to describe the management approach and guideline of COVID-19 disease in pediatric and adolescent population which may be due to mild presentation in most of cases and less severe complications than older ages.

World Health Organization was concerned with the establishment of an approved guideline to manage the increasing number of COVID-19 patients worldwide aiming to prevent or lessen COVID-19 global burden.

The clinical features have a wide spectrum starting from uncomplicated mild illness, mild-moderate pneumonia, severe pneumonia, acute respiratory distress syndrome, sepsis, septic shock, and multisystem inflammatory syndrome in children.

Many important definitions

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Publication Date
Tue Feb 17 2026
Journal Name
Al–bahith Al–a'alami
DICTION (IN ARAB SATELLITE CHANNELS) A SIGNAL SYSTEM : (study of written And oral patterns)
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Communication has seen a big advancement through ages; concepts, procedures and technologies, it has also seen a similar advancement of language. What unites language and media is the fact that each one of them guides and contributes to the other; media exists and results from language and from the other sign systems, and what strengthens this connection is the symbolic language system, as media helps it by providing knowledge and information. The change that occurred through time must leave a significant trace in the media, for example Diction, which has changed concerning development and growth, also the ways and mediums of media have become manifold and widespread. This change affected the recipient whether it was a reader, listener o

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Publication Date
Tue Feb 17 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Immunohistochemical expression of basic fibroblast growth factor-2 and Heparanase in salivary pleomorphic adenoma
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Background: The aim of this study was to evaluate the expression of fibroblast growth factor-2 and Heparanase in salivary pleomorphic adenoma, and to correlate the two studied markers with each other and with clinicopathological parameters including: age, sex, tumor site and histopathological presentation. Methods: Sections of twenty five formalin-fixed paraffin embedded tissue blocks specimens of salivary pleomorphic adenoma were immunostained using monoclonal antibodies (Fibroblast growth factor-2 and Heparanase) to assess their expression in this tumor. Results: The expression of fibroblast growth factor-2 and Heparanase were positive in all pleomorphic adenoma cases (100%). The positive expression of fibroblast growth factor-2 was signi

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Publication Date
Sun May 01 2022
Journal Name
Revue Française D'allergologie
Indoor house dust-borne fungi and risk of allergic respiratory diseases in Baghdad city
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