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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Oct 17 2015
Journal Name
Monthly Notices Of The Royal Astronomical Society
Line and continuum variability in active galaxies
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Publication Date
Mon Dec 30 2019
Journal Name
College Of Islamic Sciences
Extremism in religion Causes, effects and treatment
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Praise be to God, Lord of the worlds, and prayers and peace be upon His messenger, the mercy of the worlds.
As for after ....
It is clear from the legal texts in the Noble Qur’an and the Sunnah of the Prophet, that Islam is a method that interferes in everything in beliefs, worship, behavior and transactions, and it forbids excess and extremism and mistrust of people and looking at them through a black lens, self-conceit and contempt of others.
In our research, we will try, God willing, to study the phenomenon of religious extremism with its comprehensive dimensions, the position of Islam on it through the verses and hadiths discussed by it, and the diagnosis of the reasons for its emergence and emergence, because if we learn

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Publication Date
Mon Sep 30 2019
Journal Name
College Of Islamic Sciences
Parasycology and scientific miracles in Islamic thought
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The research sheds light on the subject of phraseology as an important field to present metaphysical issues with contemporary scientific discourse. (Primary psychology) It does not apply with the reality of this science and therefore some tried to call it other names such as (Alsai), a unit of measurement of energy activity of things and assets. It was also called metaphysics or metaphysics, but it eventually settled on parapsychology. We try to win Islam and religious concepts with contemporary scientific discourse. The researcher discussed issues that modern science was unable to comprehend and interpreted. He used these subjects to prove the truths of religion and faith. Modern times because the whole universe miracles or as Imam Ghaz

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Publication Date
Tue Oct 31 2023
Journal Name
College Of Islamic Sciences
Child custody and protection In Islamic jurisprudence
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Praise be to God, Lord of the Worlds, and prayers and peace be upon our Master Muhammad and upon all his family and companions:
And then: What most concerns rational people and reformers in the modern era is the moral deviation and delinquency that dominates childhood, due to family disintegration and the lack of discipline of most societies according to the religious and moral motives called for by the heavenly messages, especially Islam, which is the final message and guarantees the reform of people in life. Every time and place.
Islam has drawn attention to this issue (childhood) and made it the focus of its consideration, considering that the child is the nucleus of society and the preparation for the future, so it ordered that

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Publication Date
Thu Oct 01 2015
Journal Name
Journal Of Educational And Psychological Researches
Teaching and Education manners in Islamic legacy
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Learning education in the Islamic legacy vision considers a completed The Islamic learning education took its bases from origins of Quran and honored prophet Suna , and stressed on education child a good education and providing him with principles of religion and semantic moral values and Messenger (peace on him) considers the higher example for man in his moral, behavior and goodness and witness on this Higher God said

(you had in God Messenger a good leadership for those were requesting God and last day and mentioned God a lot). Al- Ahzab Surah :21. learning education converts man from religion to another and from culture to another and teacher left his signs on the generation if he accept or refuse.

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Publication Date
Mon Feb 04 2019
Journal Name
Journal Of The College Of Education For Women
Society and Manner in Joseph Conrad's Victory
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In his novel entitled Victory. Joseph Conrad asserts himself as a writer for man
as a moral agent in this universe. His characters exhibit the possibilities for isolation
and moral deterioration in modern life. The aim of this research is to investigate some
social issues that touch the core of humanity. In this novel, Conrad's perceptive eyes
has noted so many social issues that need to be tackled. Implicitly and explicitly,
Conrad launches so many controversial issues like : communication and
disengagement or skepticism , conflict between heart and mind ,fate, demonic
identification sense of guilt in man, men , women and homosexuality, the clash
between the civilized and the raw ,the disregarded local people and

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Publication Date
Thu Feb 19 2026
Journal Name
Al-academy
Hijab and Burqa in Islamic Fashion System
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Publication Date
Mon Feb 19 2018
Journal Name
Al-academy
Domination and motivation in Mona Saudi sculptures
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This research is the subject of "Domination and Motivation in the Sculptures of Mona the Saudi" to the study of an accomplished Arab sculptor with its varied sculptural activity between the works of the exhibition and the works of the squares, as well as its distinguished place among the contemporary Arab sculptors. This research is divided into four chapters:

     The first chapter deals with the general methodological framework of the research in terms of the research problem which is focused on the question: What is the hegemony and motivation in the sculptures of Mona Saudi? The importance of research and the need for it, including the technical scientific material concerned with the sculptural achievement of t

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Publication Date
Fri Feb 14 2020
Journal Name
Journal Of Mechanical Engineering Research And Developments
Noise effects in skill discretion and modeling
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Diesel generators is widely used in Iraq for the purpose of maintaining electric power demand. Large number of operators engaged in this work encounters high level of noise generated by back pack type diesel generators used for this purpose. High level of noise exposure gives different kinds of ill effect on human operators. Exact nature of deteriorated work performance is not known., in present research , quastionaire was adsministered 86 repondents in Baghdad city were exposured to wide range of noise level (80-110) dB(A) with different ages and they have different skill discretion levels. Noise levels A-weigthed decibles dB(A) were measured over 8 weeks two times aday during the 2019 summer using a sound level meter.For predicting the wo

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Publication Date
Wed Mar 15 2023
Journal Name
Al-academy
Becoming and integrative film in postmodern cinema
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The subject of the tagged research (becoming and integration of the film in postmodern cinema) is summarized by studying the transformations and complementarity of the film in light of the emergence of the concern of postmodernism. Then the need for it, as well as the objectives of the research and clarify its limits, as well as its importance. Then the transition to the theoretical framework, which included two sections, the first topic was entitled: Postmodern Cinema Formation and Completion, while the second topic was entitled: Paradox in Postmodern Film.

After completing the theoretical aspect, the research concluded with a number of theoretical framework indicators that were adopted as a tool for analyzing the sample, then th

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