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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Taxonomical and Comparative morphological study for two wild species of the genus Chaenorhinum (D.C.) Reichb. (Scrophulariaceae) in Iraq.
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Comparative morphological study has been treated for two species of the genus Chaenorhinum (D.C.) Richb., These species were: 1. Chaenorhinum calycinum 2. Chaenorhinum rubrifolium (Robill. & cast. Ex Lam. & DC.) Fourr. The genus belong to the family Scorphulariaceae. Morphological characters has been studies for: root, stem, leaves, flowers (calyx, corolla, androcium including filaments and anthers, gynocium including ovary, style and stigma), fruits and seeds also has been characterized. Key for there two species presented using some quantitative characters. Other characters like shape of fruits and seeds were used too, and they were of a useful taxonomic value

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Publication Date
Mon Jan 01 2018
Journal Name
Journal Of Physical Education
Designing and Standardizing two Passing tests for the Initial selection of Individuals With Simple Mental Disabilities In Futsal
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The five-a- Side Soccer for people with a minor mental disability has become as important as many other sporting events. Therefore, the researcher considers that the basic skills tests are suited to the level of the tested individuals in terms of their age and mental ability. The technical aspects were adopted as a means of selecting from They are qualified to practice this game in the simplest form, so show the importance of the problem of research through the design and codification of two tests of handling skills belonging to this category and adopted by the training cadres during the selection process. The research community for people with minor mental disabilities determines the male category of the mental and social disability instit

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Publication Date
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Taxonomical and Comparative morphological study for two wild species of the genus Chaenorhinum (D.C.) Reichb. (Scrophulariaceae) in Iraq.
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Comparative morphological study has been treated for two species of the genus Chaenorhinum (D.C.) Richb., These species were: 1. Chaenorhinum calycinum 2. Chaenorhinum rubrifolium (Robill. & cast. Ex Lam. & DC.) Fourr. The genus belong to the family Scorphulariaceae. Morphological characters has been studies for: root, stem, leaves, flowers (calyx, corolla, androcium including filaments and anthers, gynocium including ovary, style and stigma), fruits and seeds also has been characterized. Key for there two species presented using some quantitative characters. Other characters like shape of fruits and seeds were used too, and they were of a useful taxonomic value

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Publication Date
Wed Mar 01 2017
Journal Name
Journal Of Al-nahrain University-science
Cytological Effects of Mutagenic Agents and NaCl on Mitotic Division in Two Iraqi Rice (Oryza sativa L.) Genotypes
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This study was carried out to determine the effects of NaCl (0.00, 50, 100, 150, 180 or 200) mM and two different types of mutagens chemical mutagen ethyl methyl sulphonate (EMS) at 0.5% and physical mutagen UV-B irradiation (40 min time exposure), on mitotic division in two Iraqi rice genotypes Amber 33 (A33) and Amber Baghdad (AB). Different concentrations of NaCl were used. Mitotic index (MI %) was decreased significantly by increasing NaCl concentration, however the highest mitotic index was recorded in mutated genotypes with EMS and UV-B. Different abnormal chromosomes were noticed in mutated plants. Results showed high percentage of abnormal chromosomes in EMS mutated genotypes. In addition no significant differences between genotypes

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Publication Date
Tue Dec 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Cognitive Bias and Organizational Inertia are Two Functions of Strategic Change An Experimental Study in Amman Stock Market
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The research aims at considering the reality of cognitive bias and organizational inertia as determinants of strategic change in a sample of companies listed in Amman Stock Market. To achieve objectives of the research, a model consisting of two independent variables has been designed, namely:

(1) The cognitive bias resulting from (escalating commitment, analogy, previous assumptions, representative generalization, command and control, convergent thinking), and (2) Organizational inertia due to (Icarus discrepancy, power distribution, rooted organizational culture), and a dependent variable, strategic change in (leadership patterns, strategy, the organization per se). 

From the model two main hypotheses were derived;

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Publication Date
Mon Aug 11 2025
Journal Name
Journal Of Physical Education
Designing and Standardizing two Dribbling Tests for the Initial selection of Individuals With Simple Mental Disabilities In Futsal
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The game of football is one of the most popular games in the world because of its beauty in the hearts of its fans. From this position, the game of five football for people with simple mental disability has become as much attention to many other sporting events, so the researchers believe that the tests of basic skills match the level of individuals tested In terms of their age and mental ability, the technical aspects were adopted as a means of selecting those who are qualified to practice this game in the simplest form, so the importance of the research problem in designing and standardizing two dribbling skating tests for members of this category and It depends by training their cadres during the selection process. The research community

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Publication Date
Thu Jun 30 2016
Journal Name
Journal Of Madenat Al-elem University College
Histopathological changes induced after oral administration of acetamiprid in kidneys of male albino mice
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Publication Date
Sun Apr 16 2017
Journal Name
Tikrit Journal For Dental Sciences
Evaluation of Apical Transportation and Curve Straightening of Curved Root Canals after Preparation with Different Nickel - Titanium Rotary Systems (Comparative in Vitro Study)
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The goals of endodontic preparation were to shape and clean the space of the root canal and remove microorganisms, affected dentin and pulp, the apical foramen and the canal curve should be protected from being transported during endodontic canal preparation. The aim of this study was to evaluate the curve straightening of curved root canals and apical transportation after preparation with four rotary systems. Forty mesial roots of the lower 1st molars teeth only the mesiobuccal canals were used, these roots were immersed into cold clear acrylic , the teeth roots divided into four groups according to rotary system used for preparation of the canals (ten roots for each group):. group I: ProTaper Next rotary system, group II: IRaCe Plus rotar

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Publication Date
Fri Oct 02 2020
Journal Name
Biochem. Cell. Arch.
MORPHOLOGICAL DESCRIPTION AND COMPARATIVE HISTOLOGICAL STUDY OF THE LIVER IN TWO IRAQI MAMMALS : WEASEL (HERPESTES JAVANICUS) AND EASTERN GRAY SQUIRREL (SCIURUS CAROLINENSIS
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The results of the current study showed that the liver of H. javanicus appeared as large lobulated organ divided into six distinct lobes, that filled the cranial region and little extended to the middle region of abdominal cavity. On the other hand, liver of S. carolinensis laid against the diaphragm, occupied the cranial region of the abdominal cavity and consisted of five lobes. The liver is surrounded with a thin capsule of dense regular collagenous connective tissue and few numbers of smooth muscles fibers can be seen in the capsule that covered the squirrel liver. The liver parenchyma divided into a large number of interconnected hepatic lobules marked only by the abundant amount of connective tissue bordered the triads, and within the

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Publication Date
Fri Sep 30 2016
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Parameters Affecting the Thermodynamic Efficiency of PEM Single Cell and Stack of Cells (Two Cells)
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In this work, thermodynamic efficiency of individual cell and stack of cells (two cells) has been computed by studying the variation of voltage produced during an operation time of 30 min as a result of the affected parameters:- stoichiometric feed ratio, flow field design on single cell and feed distribution on stack of cells. The experiments were carried out by using two cells, one with serpentine flow field and the other with spiral flow field. These cells were fed with hydrogen and oxygen at low volumetric flow rates from 1 to 2 ml/sec and stoichiometric ratios of fuel (H2) to oxidant (O2) as 1:2, 1:1 and 2:1 respectively. The results showed that

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