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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Jan 30 2024
Journal Name
International Journal Of Engineering Pedagogy (ijep)
The Impact of Two Proposed Strategies Based on Active Learning on Students' Achievement at the Computer and Their Social Intelligence
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Active learning is a teaching method that involves students actively participating in activities, exercises, and projects within a rich and diverse educational environment. The teacher plays a role in encouraging students to take responsibility for their own education under their scientific and pedagogical supervision and motivates them to achieve ambitious educational goals that focus on developing an integrated personality for today’s students and tomorrow’s leaders. It is important to understand the impact of two proposed strategies based on active learning on the academic performance of first-class intermediate students in computer subjects and their social intelligence. The research sample was intentionally selected, consis

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Publication Date
Thu Dec 01 2011
Journal Name
Engineering Analysis With Boundary Elements
Numerical solution of two-dimensional mixed problems with variable coefficients by the boundary-domain integral and integro-differential equation methods
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Publication Date
Sun Jun 06 2010
Journal Name
Baghdad Science Journal
Comparison between the efficiency of serological tests for Identification of Brucellosis
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Five serological methods for detection of Brucella were compaired in this study, Four of the methods are commonely used in the detections:- 1-Rose-Bengal: as primary screening test which depends on detecting antibodies in the blood serum. 2-IFAT: which detects IgG and IgM antibodies in the serum. 3-ELISA test: which detects IgG antibodies in the serum. 4-2ME test: which detects IgG antibodies The fifth methods. It was developed by a reasercher in one of the health centers in Baghdad. It was given the name of spot Immune Assay (SIA). Results declares that among (100) samples of patients blood, 76, 49, 49, 37, and 28. samples were positive to Rose Bengal, ELISA, SIA, 2ME and IFAT tests, respectively. When efficiency, sensitivity and specific

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Publication Date
Fri Aug 30 2019
Journal Name
Environmental Engineering Research
Numerical modeling of two-dimensional simulation of groundwater protection from lead using different sorbents in permeable barriers
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This study is to investigate the possibility of using activated carbon prepared from Iraqi date-pits (ADP) which are produced from palm trees (Phoenix dactylifera L.) as low-cost reactive material in the permeable reactive barrier (PRB) for treating lead (Pb<sup>+2</sup>) from the contaminated groundwater, and then compare the results experimentally with other common reactive materials such as commercial activated carbon (CAC), zeolite pellets (ZP). Factors influencing sorption such as contact time, initial pH of the solution, sorbent dosage, agitation speed, and initial lead concentration has been studied. Two isotherm models were used for the description of sorption data (Langmuir and Freundlich). The maximum lead sorp

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Publication Date
Thu Jun 18 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of bone density after six months from dental implants placement using Computed Tomography
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Background: Determination of local bone mineral density (BMD) immediately after implant insertion play an important role in implant success rate, may offer comprehensive description of the bone, and give enough information to the surgeon prior to implant insertion and at follow up status. The aim of the present study is to evaluate the changes of local bone density in the dental implant recipient sites by using computerized tomography. Material and method: The sample consisted of (20) dental implants recipient sites, bone density assessment was done twice, immediately after implants insertion and after six months. Results: The mean HU of the bone around the implant insertion site, immediately after implant placement was 552.28 HU, and inc

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Publication Date
Sun Sep 22 2019
Journal Name
Baghdad Science Journal
Thermal Conductivity Performance of Silica Aerogel after Exposition on Different Heating under Ambient Pressure
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         The varied thermal conductivity (insulation) of silica aerogel with heating for different pH has been investigated, it has been depended on ambient pressure drying method in the preparing silica aerogel samples, also six different pH of samples (1, 2, 3, 7, 8 and 9) were treated under five degree of heating with (50,100,150,200 and 250) ᴼC. This technique is important to test the carry-outs hydrophobic silica to temperature without high-quality material changes in the basic characteristics. The hot-wire technique is used in this work to examine the thermal conductivity, Fourier Transform Infrared Spectroscopy (FTIR) depended to characterize the bonds and their artificial by heating. Resu

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Publication Date
Fri Feb 08 2019
Journal Name
Iraqi Journal Of Laser
A 980nm Diode Laser Clot Formation of the Rabbit’s Dental Sockets after Teeth Extraction
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The aim of this research work is to evaluate the use of 980 nm diode laser in clotting the blood
in the bone socket after tooth extraction. The objective is to prevent possible clot dislodgement which is
a defect that may lead to possible infection. A number of rabbits were irradiated using 980nm CW mode
diode laser, 0.86W power output for 9s and 15s exposure time. The irradiated groups were studied
histopathologically in comparison with a control group. Results showed that laser photothermal
coagulation was of benefit in minimizing the possibility of the incidence of postoperative complications.
The formation of the clot reduces the possibility of bleeding and infection.

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Publication Date
Mon Jun 01 2026
Journal Name
Journal Of Engineering
Temporal Shifts in Understanding of Privacy: Perspectives of House Users in Baghdad During Two Different Periods: Case Studies in Selected Neighborhoods
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The Dwelling is a Fundamental issue related to human beings; throughout time, man has always had to dwell in a place and build his house. Due to different styles and typologies appearing all over the world, all containing the character of privacy as the main element of human life in their dwellings. The present study aims to investigate the temporal shift in understanding privacy during the 20th and 21st centuries in Baghdadi houses, and what are the physical elements that are related to the meaning of privacy? The research methodology analyzed the concepts of privacy to extract the research indicators to be applied to (49) samples of individual houses in selected neighborhoods in two different periods. The data was collected from v

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Publication Date
Mon Mar 08 2021
Journal Name
Baghdad Science Journal
Effect of growth regulators on responsible rooting for two varieties
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Conducted two trials separate plants Defla first two seasons, 1998 and 1999 to test the susceptibility Altgveria three varieties including Azharha colored white and pink Qati and pink Qtmr and second seasons 1999 and 2000, two types color Azhaarhama white and pink Qati treated mind half-timbered two types of Alaoxinat IBA and NAA and three concentrations as well as repeatersAdhrt results low Almaah rooting

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Publication Date
Mon May 04 2009
Journal Name
Journal Of Al-nahrain University
Solution of two-dimensional fractional order volterra integro-differential equations
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In this paper, our aim is to study variational formulation and solutions of 2-dimensional integrodifferential equations of fractional order. We will give a summery of representation to the variational formulation of linear nonhomogenous 2-dimensional Volterra integro-differential equations of the second kind with fractional order. An example will be discussed and solved by using the MathCAD software package when it is needed.

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