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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 24 2023
Journal Name
Archives Of Razi Institute
PCR-RFLP Analysis of Insulin-Like Growth Factor 2 Gene Polymorphisms in Two Commercial Broiler Chicken Strains (Cobb 500 and Hubbard F-15) and Their Associations with Performance Traits
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The present research aimed to study the polymorphisms of the chicken insulin-like growth factor 2 (IGF2) in two commercial broiler breeds (Cobb 500 and Hubbard F-15). In total, 300 avian blood samples were obtained. The genomic DNA was isolated using a fast salt-extraction technique. Moreover, polymerase chain reaction (PCR) was used to amplify 1146 bp fragments of the gene. The amplified fragments were subjected to restriction enzyme digestion using the HinfI endonuclease enzyme, and the digested products were separated on a 2% agarose gel. The findings indicated that there were two alleles, T and C, for the target locus, with frequencies of 73.3% and 26.7%, respectively. Three distinct genotype variations, TT, TC, and CC, were found, with

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Publication Date
Sun Nov 01 2020
Journal Name
Conference
Study the Response Of The Wind Turbine System under Realistic Working Conditions Using Simulink
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Abstract<p>In recent years, there has been a very rapid development in the field of clean energy due to the huge increase in the demand, which prompted the manufacturers and the designers to increase the efficiency and operating life of the energy systems and especially for wind turbine. It can be considered that the control unit is the main key of the wind turbines. Consequently, it’s essential to understanding the working principle of this unit and spotlight on the factors which influence significantly on the performance of wind turbine system. Simulink technique is proposed to find the response of the wind turbine system under different working conditions. In this paper, it was investigated</p> ... Show More
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Publication Date
Wed Jul 31 2019
Journal Name
Journal Of Engineering
Buckling Analysis of Laminated Composite Plate with Different Boundary Conditions using modified Fourier series
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Buckling analysis of a laminated composite thin plate with different boundary conditions subjected to in-plane uniform load are studied depending on classical laminated plate theory; analytically using (Rayleigh-Ritz method). Equation of motion of the plates was derived using the principle of virtual work and solved using modified Fourier displacement function that satisfies general edge conditions. The eigenvalue problem generated by using Ritz method, the set of linear algebraic equations can be solved using MATLAB for symmetric and anti-symmetric, cross and angle-ply laminated plate considering some design parameters such as aspect ratios, number of layers, lamination type and orthotropic ratio. The results obtained g

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Publication Date
Sun Mar 30 2003
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Improvement of CIATIM-201 Grease Properties for Use under Severe Conditions using Suitable Additives
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Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
Implementation of Optical Coherent Communication System between Two Computers
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This work represents implementation and investigation of optical coherent communication system between two computers. A single mode optical fiber is selected as transmission medium. The data are sent via the RS-232 standard interface with a bit rate of 9.6 kbps from personal computer (PC1) by line receive to convert the data from electrical levels (-12/+12 V) into TTL level (0/5 V). The modulation of this data was accomplished by internal modulation using laser diode type (HFCT-5208M) 1310 nm wavelength. The optical D-coupler was used to combine the optical signal that come from laser source with optical signal of laser local oscillator (OTS-304XI) at 1310/1550 nm wavelength to obtain coherent (homodyne and heterodyne) detection respective

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Publication Date
Sat Jun 13 2026
Journal Name
Journal Of Engineering
Computational Method for Unsteady Motion of Two-Dimensional Airfoil
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A numerical method is developed for calculation of the wake geometry and aerodynamic forces on two-dimensional airfoil under going an arbitrary unsteady motion in an inviscid incompressible flow (panel method). The method is applied to sudden change in airfoil incidence angle and airfoil oscillations at high reduced frequency. The effect of non-linear wake on the unsteady aerodynamic properties and oscillatory amplitude on wake rollup and aerodynamic forces has been studied. The results of the present method shows good accuracy as compared with flat plate and for unsteady motion with heaving and pitching oscillation the present method also shows good trend with the experimental results taken from published data. The method shows good result

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Publication Date
Sat Jul 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Performance Evaluation of Two Date Palm Frond Cutting Saws
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Abstract<p>Traditional tree management is laborious and costly, thus this work aimed to study the performance of two different types of frond cutting saws (reciprocating saw and vibrating saw) and examine the two saws on five date palm varieties. Four parameters were examined, including cutting time for a single frond, the power needed for cutting a single frond, frond cutting productivity expressed as tree/h, and vibration conveyed to the worker’s hand. A field experiment was designed according to the nested randomized complete block design, including five date palm varieties as the main plot and the type of saw as a sub-plot. Means were compared using the least significant differences (LSD 0</p> ... Show More
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Publication Date
Wed Aug 23 1989
Journal Name
J. Agric. Water Reso. Res 8 (1), 11-25‏
Response Of Two Barley Mutants CV. Arivat To Salinity‏
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Publication Date
Thu Mar 01 2018
Journal Name
Journal Of Engineering
Impact Response for Two Designs of Athletic Prosthetic Feet
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The present work evaluated the differences in mechanical properties of two athletic prosthetic feet samples when subjected to impact while running. Two feet samples designated as design A and B were manufactured using layers of different orientations of woven glass fiber reinforced with unsaturated polyester resin as bonding epoxy. The samples’ layers were fabricated with hand lay-up method. A theoretical study was carried out to calculate the mechanical properties of the composite material used in feet manufacturing, then experimental load-deflection  test was applied at 0 degree position and 25 degree dorsiflexion feet position  and impact test were applied for both feet designs to observe the behavior

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Publication Date
Sun May 01 2022
Journal Name
Journal Of Engineering
Parametric Study of a Two-Phase Closed Thermosyphon Loop
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A theoretical and experimental investigation was carried out to study the behavior of a two-phase closed thermosyphon loop (TPCTL) during steady-state operation using different working fluids. Three working fluids were investigated, i.e., distilled water, methanol, and ethanol. The TPCTL was constructed from an evaporator, condenser, and two pipelines (riser and downcomer). The driving force is the difference in pressure between the evaporator and condenser sections and the fluid returns to the heating section by gravity. In this study, the significant parameters used in the experiments were filling ratios (FR%) of 50%, 75%, and 100% and heat-input range at the evaporator section of 215-860.2 W. When the loop reached to

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