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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
Some Thoughts on Greetings in English and Arabic
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The present study examines the main points of differences in the subject of greetings between the English language and the Arabic language. From the review of the related literature on greetings in both languages, it is found that Arabic greeting formulas are more elaborate than the English greetings, because of the differences in the social customs and the Arabic traditions and the Arabic culture. It is also found that Arabic greetings carry a religious meaning basing on the Islamic principle of “the same or more so”, which might lead to untranslatable loopholes when rendered in English.

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Publication Date
Mon Apr 03 2023
Journal Name
The Journal Of Physical Chemistry A
Excited-State Aromaticity Reversals in Naphthalene and Anthracene
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Aromaticity reversals between the electronic ground (S0) and low-lying singlet (S1, S2) and triplet (T1, T2, T3) states of naphthalene and anthracene are investigated by calculating the respective off-nucleus isotropic magnetic shielding distributions using complete-active-space self-consistent field (CASSCF) wavefunctions involving gauge-including atomic orbitals (GIAOs). The shielding distributions around the aromatic S0, antiaromatic S1 (1Lb), and aromatic S2 (1La) states in naphthalene are found to resemble the outcomes of fusing together the respective S0, S1, and S2 shielding distributions of two benzene rings. In anthracene, 1La is lower in energy than 1Lb, and as a result, the S1 state becomes aromatic, and the S2 state becomes anti

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Publication Date
Mon Nov 26 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Serum Zinc and Copper Changes in Male Infertility
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Objective: The aim of this study to detect the correlation between trace elements such as zinc, copper and
spermatogenesis, sperm viability and motility.
Methodology: Serum and semen samples were collected from one hundred twenty patients with age ranged (20-
50 years) attending the high institute for Embryo Research and Infertility Treatment/ Baghdad University, in
addition to thirty fertile males their age comparable to that of patients. The period of this study was from June
2004 until the end of October 2004.
Results: The result of routine seminal fluid analysis of all infertile males was divided according to WHO, (1999) limit
into four groups: Asthenospermia(A), Asthenoteratospermia(AT), Oligoasthenoteratospermi

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Publication Date
Tue Jan 01 2019
Journal Name
World Journal Of Dentistry
Facial Fractures in Preschool- and School-aged Children
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Aim: The purpose of this study was to analyze the patterns of facial fractures in children and to compare them between preschool- and school-aged children. Materials and methods: This retrospective observational study included 57 children with facial fractures. The variables analyzed were the age of the patients—divided into a preschool-aged group (0–5 years) and a school-aged group (6–12 years)—gender, cause of trauma, the facial bones involved, the pattern of fracture, the modality of treatment used, the time between injury and treatment, and the postoperative complications. Results: The incidence of facial fractures in children ≤12 years was 30.2%. The patients consisted of 40 (70.2%) males and 17 (29.8%) females, and most pati

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Publication Date
Tue Jul 01 2014
Journal Name
Political Sciences Journal
Depleted Uranium And use an American in Iraq
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اليورانيوم المنضب واستخدامه امريكياً في العراق

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Publication Date
Tue Dec 06 2011
Journal Name
Journal Of Planner And Development
investment in the residential sector and its finacing
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Adopting a policy of attracting investments in all countries, whether developing or developed prevailed, especially after the global crisis, and this trend is imposed by considerations of political and development (urban, economic, and social) can be formulated as a rational policy to solve many problems related to patterns of urban growth, economic, social, and including the problem of housing. As the reality of the housing sector in Iraq will require the allocation of substantial resources to promote it by the research problem is the lack of financial resources and the inability of investments to meet the various requirements including the requirements of economic sectors, particularly in the field of housing, infrastructure an

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Publication Date
Sat Sep 30 2023
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Tax Justice and its Effect in Tax Compliance
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Abstract

                 The research aims to verify the dimensions of tax justice that exist in Iraq, and to determine their impact on tax compliance. Through a revised model of tax justice based on the literature of tax justice according to the classification of the studies of (Saad, 2009), (Wenzel, 2002), by using a questionnaire as an experimental measurement tool designed to be in line with perceptions of tax justice in Iraq. To define the dimensions of tax justice (the independent variable) with eight dimensions (Distributive justice, Exchange justice, Vertical justice, Horizontal justice, Retributive justice,

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Publication Date
Thu Jun 02 2011
Journal Name
Вестник Воронежского государственного университета. Серия: Лингвистика и межкультурная коммуникация
direct and indirect nomination in single-component characteristics...
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Publication Date
Sat Oct 01 2016
Journal Name
Journal Of Engineering
Intelligence in Construction between Contemporary and Traditional Architecture
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The authentic traditional architecture proved that it is very convenient to the environmental and social regulations where it appeared and lasted for hundred of years.

This traditional architecture got the intelligence in providing thermal comfort for their occupants by the intelligent usage of the building materials and the intelligent planning and designs which took in consideration the climatic condition and the aerodynamics of the whole city as one ecological system starting from the cold breeze passing through its narrow streets till it enters the dwelling units and glides out through the wind catchers.

This architecture had been neglected and replaced by modern imported architecture which had collap

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Publication Date
Mon Mar 27 2023
Journal Name
Recent Progress In Science And Technology
Recent Progress in Science and Technology Vol. 8
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