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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Jun 03 2024
Journal Name
Research Journal Of Chemistry And Environment
Molecular study of two medicinal leech species
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he genus Hirudo is an invertebrate animal that got major concerns to human. However, genetics of Hirudo has been unwell considered in Iraq. In order to gain a deeper understanding in the outline of the genetic of Hirudo that were used in alternative medicine clinics, nineteen specimens of Hirudo were obtained. Fourteen of them (H.verbana, n=10; H. orientalis, n=4) were obtained from some different clinics and scientific centres in Baghdad, Iraq between January and March 2022, these specimens were considered as non-local leeches. The other (native isolates) leeches (H. orientalis, n=5) were collected in 2014 from two localities in Erbil, northern Iraq. ITS-2, COI and 12S-rRNA of Hirudo spp were amplified using conventional polymerase chain r

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Publication Date
Fri Feb 20 2026
Journal Name
Modern Sport
Comparison of the speed of hospitalization according to the training load of some physiological and biochemical variables of badminton players and runner800 m youth
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It is necessary to use the means of recovery and other means that help to get rid of the effects of fatigue, as the game of badminton and the effectiveness of running 800 meters fall within the mixed system with the superiority of the anaerobic system by more than the air system, so requires the development of energy systems In proportion to the time of the match for badminton players and their travels and high performance and ability to tolerate the high level of lactic acid in the muscles and blood and increase the pain associated with the fatigue that occurs during the performance. In light of the physical and physiological processes of these actions N it should seek through training programs to develop your endurance and wind energy sys

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Publication Date
Tue Dec 30 2025
Journal Name
Alnahrain Journal Of Legal Scienci
Elements and Conditions of Personal Civil Liability (Based on Fault) for the Government for Damages Caused by Demonstrations: A Comparative Study
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This study examines the position of comparative legislation (French legislation, English legislation, and Egyptian legislation) in addressing the regulation of personal civil liability (based on fault) for the government. About the damages caused by demonstrations in terms of their legal nature, their legal basis, and the pillars and conditions of that responsibility. Then, we explain the position of the Iraqi legislator and compare it with what is the case in the legislation mentioned above

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Publication Date
Sun Jun 01 2014
Journal Name
Baghdad Science Journal
Ingots Defects under the influence of Solidification and Freezing Conditions. : Farouk Mahdi Mansour|Mustafa A. Rijab Al-Najar|Amera kanan Asfur
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The results of research to reach the conditions that prevents the emergence of primary or secondary voids and achieve worker benefit from molded by almost 100%, which was the situation that cast poured in a mold heated and insulated from all sides to achieve freezing directional full starting from the region remote from the casting and ending then. Has also been compared to the microscopic structure of the resulting castings of various molding conditions, as these conditions have achieved the best sound microscopic structures.

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Publication Date
Fri Jan 01 2021
Journal Name
Fme Transactions
Unsteady nonlinear panel method with mixed boundary conditions
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A new panel method had been developed to account for unsteady nonlinear subsonic flow. Two boundary conditions were used to solve the potential flow about complex configurations of airplanes. Dirichlet boundary condition and Neumann formulation are frequently applied to the configurations that have thick and thin surfaces respectively. Mixed boundary conditions were used in the present work to simulate the connection between thick fuselage and thin wing surfaces. The matrix of linear equations was solved every time step in a marching technique with Kelvin's theorem for the unsteady wake modeling. To make the method closer to the experimental data, a Nonlinear stripe theory which is based on a two-dimensional viscous-inviscid interac

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Publication Date
Fri Feb 20 2026
Journal Name
Journal Of Studies And Researches Of Sport Education
The effectiveness of the use of yoga exercises and its impact on the reactions of the two Alvesologih nervous and respiratory systems in the correction of antenna pistol shooting accuracy
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Publication Date
Thu Oct 12 2017
Journal Name
Iraqi Journal Of Laser
A Comparative Evaluation of Post-Operative Pain and Function after Gingival Depigmentation Using 940 Nm Diode Laser And Conventional Bur Method: 6 Months Study
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The aim of the study was to evaluate the efficacy of diode laser (λ=940 nm) in the management of gingival hyperpigmentation compared to the conventional bur method. Materials and methods: Eighteen patients with gingival hyperpigmentation were selected for the study with an age between 12-37 years old. The site of treatment was the upper gingiva using diode laser for the right half and the conventional method for the left half. All patients were re-evaluated after the following intervals: 3 days, 7 days, 1 month and 6 months post-operation. Pain and functions were re-evaluated in each visit for a period of 1 day, 3 days and 1 week post-operation. Laser parameters included 1.5 W in continuous mode with an initiated tip (400 μm) placed in

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Publication Date
Sun Jun 02 2019
Journal Name
Baghdad Science Journal
Comparative Histological Study of the Stomach in Two Species of Iraqi Vertebrates (Magpie Pica pica L. and Small Asian Mongoose Herpestes javanicus E.)
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          A histological study showed the wall of the stomach in Pica pica and Herpestes javanicus consists of four layers: mucosa, submucosa, muscularis externa and serosa. Also, the present study showed many  differences in the histological structures of the stomach for each in both types. The stomach of P. pica consists of two portions: the proventiculus and gizzard, while the stomach of H. javanicus consists of three portions: cardiac, fundic and pyloric regions. The mucosa layer formed short gastric folds, named plicae. In the proventiculus of P. pica, sulcus is found between each two plicae, but the folds called gastric pits in the gizzard, which are full with koilin. Lamina properia in both types contained gastric g

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Publication Date
Sun Jun 02 2019
Journal Name
Baghdad Science Journal
Comparative Histological Study of the Stomach in Two Species of Iraqi Vertebrates (Magpie Pica pica L. and Small Asian Mongoose Herpestes javanicus E.)
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          A histological study showed the wall of the stomach in Pica pica and Herpestes javanicus consists of four layers: mucosa, submucosa, muscularis externa and serosa. Also, the present study showed many  differences in the histological structures of the stomach for each in both types. The stomach of P. pica consists of two portions: the proventiculus and gizzard, while the stomach of H. javanicus consists of three portions: cardiac, fundic and pyloric regions. The mucosa layer formed short gastric folds, named plicae. In the proventiculus of P. pica, sulcus is found between each two plicae, but the folds called gastric p

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Publication Date
Thu Sep 30 2004
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Two-Step Catalytic Conversion of Ethanol to Butadiene in a Fixed Bed
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