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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 30 2019
Journal Name
Journal Of The College Of Education For Women
The Basic Words and Terms of Sport Games and Motions in the Holy Quran : semantic study
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(( The Basic word and Terms of sports, games and motions in the Holy Quran : semantic
study )).
The research consists of apreface followed by an Introduction , and three sections and
aconclusion, finally the research concluded with a list of the sources . and also alist of terms
and word in English language for a wider use .
As for reach sections, they are section one it covers a group of words sports games that
are forty two words .
Section two : it covers five fields :-
a- A group of words ( sports ruless) that an seventeen words.
b- A group of ( sports montions ) that are ten .
c- A group of ( sports tools ) that are seven words.
d- A group of ( sports sciences ) that are seven words only .
e- A gro

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Publication Date
Mon Dec 31 2018
Journal Name
Journal Of Theoretical And Applied Information Technology (jatit)
Factors and Model for Sensitive Data Management and Protection in Information Systems’ Decision of Cloud Environment
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Journal of Theoretical and Applied Information Technology is a peer-reviewed electronic research papers & review papers journal with aim of promoting and publishing original high quality research dealing with theoretical and scientific aspects in all disciplines of IT (Informaiton Technology

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Publication Date
Sun Sep 15 2019
Journal Name
Al-academy
Synergy of Modern Technology and Artistic Aesthetics in the Cinema and Television Achievement: براق انس المدرس
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       Most of the cinema and television production relies on the use of modern digital technologies, which today become the as ideal as the artistic expressive style that sends aesthetic values ​​through the use of electronic elements of the language of cinema and television to achieve aesthetic dazzling, and design the digital production for the purpose of persuasion, as well as the use of digital effects and graphics to activate the aesthetic pleasure. The research tries to subject all these aspetcs to study and apply them to a modern sample in order to get the results that confirm this technical and artistic aesthetic synergy that leads to the emergence of a cinema and television achievement the leas

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Publication Date
Mon Jan 01 2018
Journal Name
Current Research In Microbiology And Biotechnology
Detection of some Physiological and Immunological parameters in Iraqi clinical and subclinical hypothyroid patients: Relationship study
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The present study was performed to evaluate the level of some risk factors (biochemical and immunological) in hypothyroid Iraqi patients considering the different thyroid functional states (hypothyroidism and subclinical hypothyroidism).The study includes 82 patients clinically diagnosed with hypothyroidism. Three study groups have been investigated: (47 clinical hypothyroid patients, 12 subclinical hypothyroid patients 23 healthy individuals) of different ages. This study, show that the proportion of females (83.3 %), (87.2%) in subclinical and clinical hypothyroidisim respectively higher than the proportion of males (16.7%),(12.8%) in subclinical and clinical hypothyrodism respectively of the total patients.The majority of subclinical hyp

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Publication Date
Sun Mar 01 2015
Journal Name
Journal Of Engineering
Rehabilitation of Mounemantal, Historical, and Traditional Buildings (Pilot Project strategy in Historical and Traditional Buildings Rehabilitation)
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The concept of rehabilitation provided an essential richness in the conservation philosophy through sustaining buildings life and adapting them to the contemporary use through a vision which looks at the present and future . In Iraq , the existence of historical buildings and the traditional fabric in the cities required the urban development which enhanced the interests of planning and architectural fields especially the building rehabilitation which requires the architectural intervention , and all that led to elaborate the problem of research which is " The confusion in the concepts of monumental, historical and traditional buildings in Iraq, As well as The insufficient knowledge about rehabilitation and the acts related to it through

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Publication Date
Sun Jun 03 2018
Journal Name
Baghdad Science Journal
Triterpenoid Saponins Investigation and Pharmacological (Cytotoxic and Antioxidant) Properties of Bacopa monnieri L. Cultivated in Iraq
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Bacopa monnieri L. (Scrophulariaceae), synoname is Herpestis monniera that provides bioactive compounds, especially triterpenoid saponins (Bacosides) which exhibits an important biological activities, like hypothyroidism, anticonvulsant, memory enhancing and antistress. Because there are no researches about B. monnieri L. plant that grow in Iraq, and there active compounds especially triterpenoid saponin (TS), and there effects. This study was detected the presence of (TS) in, and examined the cytotoxic and the antioxidant activity of these compounds in vitro. The study was included the extraction and identification of TS from the whole parts of B. monnieri L. by using three methods, and the best yield was analyzed by High Performance Liqui

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Publication Date
Tue May 01 2018
Journal Name
Environmental Technology & Innovation
Cultivation of Nannochloropsis oculata and Isochrysis galbana microalgae in produced water for bioremediation and biomass production
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Publication Date
Tue Dec 01 2009
Journal Name
Journal Of Economics And Administrative Sciences
The importance of improved forests in Iraq and their impact on the economic and social future
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عانت الغابات في العراق قصوراً واضحاً في مجال إشباع حاجة السكان لمنتجاتها الرئيسية المتمثلة بالأخشاب ومنتجاتها الثانوية المتمثلة بالأغصان والأوراق والنباتات الطبيعية والحيوانات البرية ونواتجها الأخرى، مما يتطلب التفكير بمحاولة إيجاد سبل جديدة لحل هذه المشكلة الاقتصادية المرتبطة بعنصريها الحاجة للأخشاب والأموال المخصصة لتطويرها عموماً.

لقد دمرت مساحات كبيرة من الغابات وحرقت وقطعت من

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Publication Date
Sun Dec 22 2019
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Perceptions and attitudes of community pharmacists towards patient counseling and continuing pharmacy education programs in Iraq
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The pharmacist's role in the community is currently directed towards providing drug information and patient care rather than drug compounding and dispensing. Patient counseling is an essential skill for pharmacists. So as to improve the pharmacist role in the community and enhance the patient's education and counseling skills, many continuing education programs are established. The aim of this study is to assess the perceptions and tendency of community pharmacists in Iraq regarding patients counseling and continuing pharmacists’ educational programs.

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Publication Date
Mon Jun 30 2025
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Assess the maturity of source rocks and their oil potential in greater Kirkuk and surrounding area
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   The region of Kirkuk and its surrounding areas, including (Baba, Jambour, Qara Chuq, Qaiyarah, Demir Dagh, Bai Hassan, Taq Taq, Makhul, Gilabat as well as southern Mosul and the cities of Erbil and Sulymania, are known as one of the oldest discovered oil fields in northern Iraq. This area presents a significant opportunity for further organic geochemical analysis to describe maturation zones and estimate economically generated hydrocarbons with particular reference to the Sargelu formation, to enhance hydrocarbons productivity. To assess the potential of these oil fields, it is essential to perform correlation, comparisons, and geochemical analyses of the data collected from exploration wells in the surrounding area. This appro

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