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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 01 2019
Journal Name
Academy Of Accounting And Financial Studies Journal
Organizational performance in Iraqi SMEs: Validity and reliability questionnaire
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Publication Date
Mon Jul 06 2020
Journal Name
International Journal Of Research In Pharmaceutical Sciences
Teenage pregnancy. Prevalence and adverse outcomes in Baghdad city
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Pregnancy at an early age of life is a major challenge. The consequences of this problem have an impact on the quality of life of the young mother and her family, and determines an important risk for her offspring. The son of a teenage mother has, in general, greater risks than that of a mother of more than 20 years. The aim of this study is to determine the prevalence and outcome of teenage pregnancy. A descriptive data base study was conducted at Al-Elwia Maternity Teaching hospital in the period from January 1, 2019 to the end of June 2019 within the age between 12 and 19 years old. The mean age of the mother was 17.4 ±1.5 years. The mean age of the father was 23.9 ± 5.7 years with (69.5%) with Vaginal delivery and most of the

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Publication Date
Fri Jun 01 2012
Journal Name
Journal Of The College Of Languages (jcl)
Sound Assimilation in English and Arabic: a Contrastive Study
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      This piece of research deals with assimilation as one of the phonological processes in the language. It is a trial to give more attention to this important process in English language with deep explanation to its counterpart in Arabic. in addition, this study sheds light on the points of similarities and differences concerning this process in the two languages. Assimilation in English means two sounds are involved, and one becomes more like the other.

     The assimilating phoneme picks up one or more of the features of another nearby phoneme. The English phoneme /n/ has t

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Publication Date
Tue Mar 19 2019
Journal Name
Political Sciences Journal
Diplomatic work and its importance in foreign policy planning
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That the diplomatic work and its importance in foreign policy planning assumes the following points: 1. Choosing the tool in the sense of choosing the most correct tool that reflects the reality of the situation on the one hand and the disposal of strong energy to reach the implementation of the political decision. The declaration of war and entering into a resolution that uses force merely to face insulting ambassadors does not mean Power of the State concerned. But an imbalance in its foreign policy. 2. The coordination of the tools, that the foreign policy scheme must be such a role, and on the external style, diplomatic work, military action and propaganda must complement each other, to the extent that each of them is the first attac

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Publication Date
Sat Dec 30 2023
Journal Name
Journal Of The College Of Education For Women
Salience and Erasure in Environmental Advertisements: An Ecolinguistic Study
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Ecolinguistics is a twofold field in which ecology and language are its two major concerns. That is, this field is concerned with the way through which our thoughts, ideologies and the like influence the environment. The present study aims at analyzing (6) constructive and destructive environmental advertisements to find out how the techniques of erasure and salience operate in these types of advertisements. It studies the linguistic expressions that achieve these techniques in the constructive and destructive advertisements. The qualitative and quantitative methods are exploited in the current study. Analyzing (6) constructive and destructive environmental advertisements in accordance with Stibbe’s (2015) model of salience and erasure

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Publication Date
Fri Oct 23 2020
Journal Name
Medico-legal Update
Pro- and anti-inflammatory Cytokines in Coronavirus Disease 2019
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Publication Date
Fri Jan 01 2021
Journal Name
Climate Action
Climate, Crop Production, and Water Resources in Western Asia
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Publication Date
Tue Sep 08 2015
Journal Name
Journal Of The Faculty Of Medicine
Sciatic nerve injection injury in children: Management and outcome
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W Tarik A, AW Ali T, Journal of the Faculty of Medicine, 2015 - Cited by 2

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Publication Date
Wed May 01 2019
Journal Name
Iop Conference Series: Materials Science And Engineering
The city’s ecological applications and standards in ALAMARA city
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Abstract<p>In the last period there have been rapid developments and increased interest in the integration of the environment into urban planning. It has occupied a large part of the world’s most economically and economically important concerns, emphasizing the need to adopt the concepts of green urban construction as a basis for future cities. Both human and nature to continue and stay. Hence, the importance of research in building a base on the planning and design principles of the eco-friendly city for the purpose of local adoption”, thus facing the problem of” lack of application of knowledge on the basis of planning and design eco-friendly city. The hypothesis that “the development </p> ... Show More
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Publication Date
Sun Dec 01 2019
Journal Name
Academic Medicine
Academic medicine and science diplomacy: medical education in Iraq
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Physicians are infrequently selected to serve in the yearlong role of Jefferson Science Fellow (JSF) as senior science advisor for the US Department of State or the United States Agency for International Development. The authors discuss the role of a JSF in promoting “science diplomacy” from the perspective of one alumnus, who sites examples of ongoing, long-term collaborative projects including one focusing on medical education reform in Iraq that would not have been possible without the JSF program. More than 3 decades of political and social unrest, terrorism, the internal displacement of millions of Iraqi citizens, the arrival of Syrian refugees, international sanctions, and the effect of fluctuating oil prices that fund education i

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