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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Apr 04 2025
Journal Name
European Journal Of Dentistry
The Effectiveness of Conventional and Advanced Aligning Archwires: The Insights of Two Randomized Clinical Trials
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Abstract<p> Objectives This study aimed to compare the clinical effectiveness of four aligning archwires: Superelastic Nickel-Titanium (Superelastic-NiTi), SmartArch, Copper-Nickel-Titanium (Cu-NiTi), and Speed Tubular coaxial-Nickel-Titanium (Tubular coaxial-NiTi), regarding the alignment efficiency, associated perception of pain, and possibility of inducing root resorption.</p><p> Materials and Methods This study includes two randomized clinical trials run in parallel. Patients with 5 to 9 mm of mandibular anterior teeth crowding according to Little's irregularity index (LII) who needed fixed orthodontic appliances without extraction were randomly assigned to four groups of</p> ... Show More
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Publication Date
Sun Jan 01 2023
Journal Name
Aip Conference Proceedings
Sliding mode control based on high-order extended state observer for flexible joint robot under time-varying disturbance
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Abstract. In this paper, a high order extended state observer (HOESO) based a sliding mode control (SMC) is proposed for a flexible joint robot (FJR) system in the presence of time varying external disturbance. A composite controller is integrated the merits of both HOESO and SMC to enhance the tracking performance of FJR system under the time varying and fast lumped disturbance. First, the HOESO estimator is constructed based on only one measured state to precisely estimate unknown system states and lumped disturbance with its high order derivatives in the FJR system. Second, the SMC scheme is designed based on such accurate estimations to govern the nominal FJR system by well compensating the estimation errors in the states and the lumped

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Publication Date
Thu Feb 01 2024
Journal Name
Infrastructures
Strength and Deformation of Concrete-Encased Grouting-Filled Steel Tubes Columns Exposed to Monotonic Quasi-Static Loading Conditions
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This study aimed to evaluate the effectiveness of a novel concrete-encased column (CE) using small circular steel tubes filled with cementitious grouting material (GFST) as the primary reinforcement instead of traditional steel bars. The research involved three different types of reinforcement: conventional steel bars, concrete-filled steel tubes with 30% of the reinforcement ratio of steel bars, and concrete-filled steel tubes with the same reinforcement ratio as steel bars. Twenty-four circular concrete columns were tested and categorized into six groups based on the type of reinforcement employed. Each group comprised four columns, with one subjected to concentric axial load, two subjected to eccentric axial load (with eccentrici

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Publication Date
Sat Oct 01 2016
Journal Name
2016 Ieee Nuclear Science Symposium, Medical Imaging Conference And Room-temperature Semiconductor Detector Workshop (nss/mic/rtsd)
Comparison of columnar and pixelated scintillators for small field of view hybrid gamma camera imaging
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Publication Date
Sun Dec 30 2012
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Production of Biodiesel Fuel from Oleic Acid and Comparison of its Properties with Petroleum Diesel
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Biodiesel define as the mono-alkyl esters of vegetable oil and animal fats is an alternative diesel fuel that is steadily gaining attention because the combustion of fossil fuels such as coal, oil and natural gas has been identify as a major cause of the increase in the concentration of carbon dioxide in the earth’s atmosphere and causing global warming.
The present work concerns with estimating the physical properties experimentally such as kinematic viscosity, density, flash point and carbon residue of biodiesel that produced by the esterification reaction of methanol and oleic acid with homogeneous catalysts H2SO4 in a lab-scale packed reactive distillation column using the best operating conditions of methanol to oleic acid 8:1,

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Publication Date
Sun Dec 01 2019
Journal Name
Engineering, Technology &amp; Applied Science Research
Experimental and Numerical Comparison of Reinforced Concrete Gable Roof Beams with Openings of Different Configurations
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This paper demonstrates an experimental and numerical study aimed at comparing the influence of openings of different configurations on the flexural behavior of reinforced concrete gable roof beams. The experimental program consisted of testing six simply supported gable beams subjected to mid-point concentrated load. The variable which has been investigated in this work was opening's configuration (quadrilateral or circular) with the same upper and lower chords depth. The results indicate improvement in the beams’ flexural behavior when circular openings were used compared with that of quadrilateral openings, represented by an increase in ultimate load capacity and a decrease in deflection at the service limit. Also, there was an

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Publication Date
Mon Dec 30 2024
Journal Name
مجلة الكوفة للعلوم القانونية والسياسية
MANIPULATION OF SOFT POWER IN THE US COMPREHENSIVE STRATEGY TOWARDS FRANCE AFTER 2001
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Although the events of September 2001 marked the United States' employment of solid forces in its direct comprehensive strategy to counter terrorist organizations and any other challenges to US national security, the United States did not lose sight of the importance of the cultural variable. The cultural variable is the United States' most important instrument of soft power in ensuring its dominance of the international system and promoting its global project. France viewed US soft power as a threat to its own civilizational pattern. Therefore, France considers culture to be an inherent component of its national personality and a cornerstone of its international standing as a major force. Additionally, the US-French political and economic

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Publication Date
Fri Sep 08 2023
Journal Name
Hammurabi Journal For Studies
The Impact of the Political Process on Government Stability in Iraq After 2003
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The research in the variables of the political process and government stability tried to show the impact of the political process on political stability first, and then on government stability second, given that the political process that was established in 2005 was aimed at achieving legitimacy, and its most prominent tools are elections, leading to achieving political stability, including government stability. The issue of governmental stability is one of the important issues in Iraq, but it has not been achieved, as a result of several factors, including problems in political action, as the political process has not succeeded in leading Iraq to stability.

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Publication Date
Sat Oct 01 2022
Journal Name
Baltic Journal Of Law & Politics
The position of Iraq in Russia's foreign policy after the year 2000 AD
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This research deals with the foreign policy and the Russian trends towards Iraqafter the year 2000 AD, the international variables that affect that bilateralrelationship and the importance of the position and weight of Iraq in the MiddleEast and the attempt to include Iraq in the international organizations and blocsled by China and the Russian Federation such as the Shanghai CooperationOrganization, and joining the Chinese Belt and Road project to serve interests TheIraqi economy, and an attempt to extend its influence through security alliances inthe region in general, and Iraq in particular, as the quadrilateral center of the waron terrorism in which Russia, Iran, Iraq and Syria participated, which strengthensbilateral relations between

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Publication Date
Tue Mar 19 2019
Journal Name
Political Sciences Journal
Rentierism effect on the democratic choice of the state In Iraq after 2003
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The linguistic meaning of the verse in the Arabic dictionaries applies very much to the reality of rent and its effect. This is true of economic growth as a continuous increase in real per capita income in addition to the same thing. Therefore, development does not necessarily achieve a comprehensive and structural increase of the various economic sectors. As the rent came in the sense of a terrible land open Maim any fertilized. And the camel is a ma'aya and a ra'i: that is, it goes in the pasture and returns itself. This is similar to the extraction of oil after it is ready for investment and earn its revenue as soon as it exists or is extracted by external parties. If the rent is first linked to agriculture, especially the fertile lan

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