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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 14 2011
Journal Name
Journal Of Faculty Of Medicine Baghdad
The correlation between FEV1/ FVC with Arm span to height or chest to waist ratio as an index of pulmonary function in healthy subject.
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Abstract

Publication Date
Wed Jun 20 2018
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Synthesis, Characterization and Antimicrobial Evaluation with DFT Study of New Two-Amino-4-(4-Chlorophenyl) Thiazole Derivatives
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2-amino-4-(4-chloro phenyl)-1,3-thiazole (1) was synthesized by refluxing thiourea with para-chloro phenacyl bromide in absolute methanol. The condensation of amine compound (1)  with phenylisothiocyanate in the presence of pyridine will  produce 1-(4-(4-chlorophenyl)thiazol-2-yl)-3-phenylthiourea(2), which is  upon treatment with 2,4 dinitrophenyl hydrazine by conventional method, afforded 1- ( 4 - ( 4 – chlorophenyl ) thiazol – 2 – yl ) – 3 - phenylhydrazonamide,N' - ( 2 , 4 -dinitrophenyl) ,(3).The characterization of the titled compounds were performed utilizing FTIR spectroscopy, 1HNMR and CHNS elemental analysis, and by me

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Publication Date
Fri Mar 15 2019
Journal Name
Al-khwarizmi Engineering Journal
Effect Use of Two Chemical Compounds Sodium Nitrate and Sodium Silicate as Corrosion Inhibitor to Steel Reinforcement
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Corrosion of steel reinforcement is one of the biggest problems facing all countries in the world like bridges in the beach area and marine constructions which lead to study these problems and apply some economical solutions. According to the high cost of repair for these constructions, were studied the effect of using kind of chemical compounds sodium nitrite(NaNO2) and sodium silicate(Na2SiO3) as corrosion inhibitors admixture for steel bars that immersed partially in electrolyte solution (water + sodium chloride in 3% conc.) (Approximately similar to the concentration of salt in sea water). The two inhibitors above added each one to the electrolyte solution at concentrations (0.5%, 1% and 2%) for both

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Publication Date
Thu Jun 30 2011
Journal Name
Al-khwarizmi Engineering Journal
Extraction of Zn (II) and Cu (II) Ions Using PEG (300) - KCl Salt Aqueous Two-Phase Systems
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In this paper the process of metal ions extraction (Zn(II) and Cu(II)) was studied in PEG-KCl aqueous two phase system was investigated without using an extracting agent. The experimental runs were performance at constant temperature (25 oC), constant mixing time (30 min), and constant PH of the solution (about 3). The effect of KCl salt concentration (from 10% to 25%), volumetric phase ratio of PEG solution to KCl solution (from 0.5 to 2), and the initial metal ion concentration (from 0.25 ml to 2 ml of 1 gm/L solution) were investigated on the percent extraction of Zn(II) and Cu(II). The results indicated that the percent extraction of metal ions increase with increasing of salt concentration and phase ratio, and slightly de

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Publication Date
Mon Oct 01 2018
Journal Name
2018 International Conference On Advanced Science And Engineering (icoase)
Real-Time Face Tracking and Recognition System Using Kanade-Lucas-Tomasi and Two-Dimensional Principal Component Analysis
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Publication Date
Sun Apr 04 2010
Journal Name
Journal Of Educational And Psychological Researches
The effect of two treatment methods in the gaining of fourth grade students in geography object.
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research aim :
- The research aimed to investigate the effect of two treatment
methods in the gaining of fourth grade students in geography
object.
- Research hypothesis
 there are no statistically significant differences at the level of ( 0.05 )
in the average level of achievement in geography between the first
experimental group ( strengthening lessons ) and the second group
( re- teaching )
 no individual differences statically significant at the level of ( 0.05 )
in the average level achievement in geography object of the second
experimental group ( re- teaching ) and the first experimental group
( strengthening lesson )
 the research sample : the researcher selected randomly Baghdad

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Publication Date
Sat Nov 22 2014
Journal Name
Indian Journal Of Physics
Comparison between shell model and self-consistent mean field calculations for ground charge density distributions and elastic form factors of 12C and 16O nuclei
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Publication Date
Sat Nov 22 2014
Journal Name
Indian Journal Of Physics
Comparison between shell model and self-consistent mean field calculations for ground charge density distributions and elastic form factors of 12C and 16O nuclei
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Publication Date
Tue Oct 24 2023
Journal Name
Chemical Engineering & Technology
Electrodeposition of Manganese Dioxide under Different Conditions: Application of MnO<sub>2</sub>/Carbon Fibers in the Electrosorption Process
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Abstract<p>Anodic electrodeposition was used to synthesize a composite electrode of nanostructured manganese dioxide/carbon fiber (CF) galvanostatically. Different characterization results of the nanostructured MnO<sub>2</sub> were obtained by varying the H<sub>2</sub>SO<sub>4</sub> concentration and the current density. Field emission scanning electron microscopy, X‐ray diffraction, and atomic force microscopy were utilized to characterize the prepared composite electrodes. The best conditions were: 0.3 mA cm<sup>−2</sup> current density and 0.64 M H<sub>2</sub>SO<sub>4</sub> concentration. The electrosorption performance of the MnO<sub></sub></p> ... Show More
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Publication Date
Thu Dec 21 2017
Journal Name
International Journal Of Engineering &amp; Technology
Determination of liquefaction potential for two selected sites in Kerbala city- middle of Iraq
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Geotechnical characterization of the sites has been investigated with the collection of borehole data from different sources. Using the data, grain size distribution curves have been developed to understand the particle size distribution of the alluvium present. These curves were further used for preliminary assessment of liquefiable areas. From geotechnical characterization, it has been observed that the soil profile in the two sites is dominated by sand and silty sand.Seed and Idriss (1971) approachhas been usedevaluatethe liquefaction potentialbydeterminationof the relation between the maximum ground acceleration (a max/g) valuesdue to an earthquake and the relative density of a sand deposit in the field. The results reveal that

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