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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jan 23 2020
Journal Name
Oncology Letters
Overexpression of HURP mRNA in head and neck carcinoma and association with in�vitro response to vinorelbine
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Publication Date
Mon Sep 30 2019
Journal Name
College Of Islamic Sciences
Loqmania commandments in the Koran And its impact in the refinement of the doctrine and morals emerging
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Luqman's story stated that human instinct, if I was brought up properly, reaches wisdom and inflicts the right to everything. It is to go to worship God and adhere to the satisfaction of morals and high morals that are ordered to meet among human beings in this life, because this worship educates in the soul the most beautiful morals needed by human beings of honesty, honesty and modesty, and the work of good and virtues, and distancing the soul from evil and vices.

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Publication Date
Mon Jan 26 2026
Journal Name
Iraqi Journal Of Medical Sciences
A COMPARATIVE STUDY OF FRUCTOSE, ZINC AND COPPER LEVELS IN SEMINAL PLASMA IN FERTILE AND INFERTILE MEN
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Background: Human semen contains high concentrations of fructose, zinc (Zn) and copper (Cu) in bound and ionic forms for Zn and Cu. The presence of abnormal levels of fructose and those trace elements may affect spermatogenesis with regard to production, maturation, motility and fertilizing capacity of the spermatozoa.Objective: To evaluate the levels of fructose, Zn and Cu in seminal plasma in different groups of male infertility and to correlate their concentrations with various sperm parameters.Methods: The concentrations of fructose, Zn and Cu were measured in 114 semen samples from normozoospermic, oligozoospermic, astheno-zoospermic, and azoospermic men using the electrothermal-atomic absorption spectrometry for Zn and Cu determinatio

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Publication Date
Mon Feb 25 2019
Journal Name
Oriental Journal Of Chemistry
Viscosity and Density Studies of Drugs in Aqueous Solution and in Aqueous Threonine Solution at 298.15 K
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Publication Date
Fri Nov 30 2018
Journal Name
Oriental Journal Of Chemistry
Viscosity and Density Studies of Drugs in Aqueous Solution and in Aqueous Threonine Solution at 298.15 K
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Viscosities (η) and densities (ρ) of atenolol and propranolol hydrochloride in water and in concentrations (0.05 M) and (0.1 M) aqueous solution of threonine have been used to reform different important thermodynamic parameters like apparent molal volumes fv partial molal volumes at infinite dilution fvo , transfer volume fvo (tr), the slop Sv , Gibbs free energy of activation for viscous flow of solution ΔG*1,2 and the B-coefficient have been calculated using Jones-Dole equation. These thermodynamic parameters have been predicted in terms of solute-solute and solute-solvent interaction.

Publication Date
Fri Apr 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Private Financial Institutions and their Role in the Development of Small and Medium sized Enterprises in Iraq
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the reality of small and medium enterprises analysis reflects weaknesses plaguing these enterprises and strengths that are characterized by, and thus the formulation of appropriate solutions to the obstacles faced by these enterprises to enhance its contribution to the achievement of economic and social development. Iraqi small and medium enterprises suffer from several obstacles stand in front of development and  support their competitiveness, the finance one of the main obstacles which impede growth and development of these enterprises, noting the banking system in Iraq reluctance to lend to small and medium-sized enterprises, as a result of the high cost of lending these enterprises compared to large projects, as well as

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Publication Date
Fri Nov 28 2025
Journal Name
Arabian Journal For Science And Engineering
Role of Artificial Intelligence in Enhancing Efficiency and Sustainability in Middle Eastern Oil and Gas: A Review
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This review examines how artificial intelligence (AI) including machine learning (ML), deep learning (DL), and the Internet of Things (IoT) is transforming operations across exploration, production, and refining in the Middle Eastern oil and gas sector. Using a systematic literature review approach, the study analyzes AI adoption in upstream, midstream, and downstream activities, with a focus on predictive maintenance, emission monitoring, and digital transformation. It identifies both opportunities and challenges in applying AI to achieve environmental and economic goals. Although adoption levels vary across the region, countries such as Saudi Arabia, the UAE, and Qatar are leading initiatives that align with global sustainability targets.

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Publication Date
Thu Nov 17 2011
Journal Name
Environmental Earth Sciences
Geochemistry and mineralogical composition of the airborne particles of sand dunes and dust storms settled in Iraq and their environmental impacts
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Publication Date
Fri Jul 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
The role of Open Budget in achieving of the transparency and responsibility and Reflect it on the administrative and financial corruption
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Abstract

The open budget means everyone in the society can get information about the government budget in order to watch the governmental works. The aim of the research is to study the concepts of open budget, its advantage, limitations, role of supporting the transparency and questioning the administrative and financial corruption. Thus reflects positively on the national economy by providing governmental information to all users whether they are individuals or belong to the political class, or any other governmental or nongovernmental organizations which are interested in these information.

In order to achieve the objectives of the research aims, we make questionnaire to see aca

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
The effect of temperature and density of different host spam in efficiency and performance life of the intruder
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Studied competence spam to malicious moth figs at temperatures and Kagafat host different results showed that female intruder, despite their ability to shell larvae host and when densities of different, but it is able to lay eggs at a temperature of 14 + or -1 and finally urged the efficiency spam to malicious affected heavily host and that the greater the intensity of the host spam increased efficiency and its performance life

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