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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Feb 20 2019
Journal Name
Political Sciences Journal
Rationality and Freedom in Islamic Thought
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Abstract Rationality and freedom are fundamental elements of Western modernity. Although modern and contemporary Islamic thought has established its intellectual foundations on the fundamentals of intellectual thought that are at the core of its Islamic intellectual system, at the same time many of its intellectual products have been a response In spite of the fact that this Islamic intellectual response stands out from Western modernity as a negation or a positive attitude. The Islamic intellectual response differed in determining its position on Western modernity, depending on the nature of the historical stage that was The Islamic nation, as well as the nature of the challenge posed by Western civilization to other nations and other c

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Publication Date
Fri Apr 01 2022
Journal Name
Baghdad Science Journal
Colistin as A Good Monotherapy to Restrain the Pathogenicity of Acinetobacter baumannii In vivo and In vitro
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        Acinetobacter baumannii  (A. baumannii) is a major opportunistic nosocomial pathogen, mostly resistant to several groups of antibiotics. Colistin is now used as a last-line treatment for isolates that are highly resistant. The purpose of this study is to identify the importance of LptD; which is involved in the translocation of LPS from the inner membrane to the outer membrane in compartment with LptA and LptC of A. baumannii and its indispensable role as a virulence factor, and the efficiency of colistin as a monotherapy. In the current research, two isolates of A.baumannii were used, the local isolate HHR1 isolated from urine sample and the global strain ATCC 17904, and three antibiot

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Publication Date
Thu Mar 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
The Role Of Information Technology In Enhancing Performance Evaluation And Responsibility Accounting (Empirical Study In Jordan Hotels )
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   This paper suggesting a new modern method to evaluate the performance of hotel industry at Jordan instead of the classical method used by the industry and that is Bench Marking , this method can be done by comparing the performance of hotel industry at two serial years which helps in calculating a standard performance .

  The industry can use this standard to identify the variance, which make the evaluation of performance easier and support the efforts to develop the hotel industry at all levels and enable to give high quality services to customers.

    The study believed that this situation would not be achieved unless the hotel industry will app

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Publication Date
Sun Sep 01 2024
Journal Name
Journal Of Radiation Research And Applied Sciences
Bioaccumulation and translocation of radionuclides heavy metals in Cynodon dactylon: A phytoremediation approach in Al-Dora refinery
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Publication Date
Tue Jul 04 2023
Journal Name
Qalaai Zanist Scientific Journal
The Role of The Environmental Observer and The Environmental Police in Protecting the Environment in Iraqi Law
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Publication Date
Wed Jan 01 2020
Journal Name
Plant Archives
Effects of diseases and pests on honey bee (Apis mellifera) in different parts in Baghdad city, Iraq
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Publication Date
Sun Feb 15 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Correlation between Streptococci Mutans and salivary IgA in relation to some oral parameters in saliva of children
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Background: Saliva plays an important role in oral health. Several salivary proteins are involved in the antimicrobial defence mechanism and are able to eliminate or inhibit bacterial growth in the oral cavity. Secretory IgA (SIgA) is one of the principal antibodies present in saliva, could help oral immunity by preventing microbial adherence, neutralizing enzymes and toxins. The aim of this study was to investigate the relationship between salivary Streptococcus Mutans (SM) count and S IgA in stimulated whole saliva in children with primary dentition compared to those with permanent teeth in relation to some oral hygiene parameters. Material and methods: Stimulated whole saliva was collected from 50 children (25 with primary dentation and

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Publication Date
Sun Mar 01 2020
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Auditing performance of revenue sources in the Non-Governmental Organizations And its role in achieving financial sustainability
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Researching performance audits according to the dimensions of financial sustainability in light of the scarcity of resources and economic and social transformations in the business environment is of utmost importance in the non-profit non-governmental organizations in achieving the goals and correct the path and address deviations, and help them in improving the outputs of processes and associated procedures and capacity The research was based on the hypothesis that the existence of a performance audit program in accordance with the dimensions of financial sustainability leads to the measurement of the commitment of the Olympic Committee. National Iraqi indicators of financial sustainability of the dimension of revenue in order to improv

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Publication Date
Mon Jun 28 2021
Journal Name
Journal Of Physical Education
The Effect of Electronic Apparatus on Developing Balance in National Center for Gifted in Boxing and Basketball
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The problem of the research lies in special motor abilities training programs like the balance that positively affect coordination between the nervous system and muscles. These training programs did not get enough attention from athletes especially young athletes; their training was restricted to physical abilities like strength, speed, and endurance instead. The research aimed at designing an apparatus for developing athletes’ balance in national centers for gifted/ ministry of youth and sport so as to provide a measurement for coached in this field. The results showed that the designed apparatus have a positive effect on developing the subjects’ balance in boxing and basketball athletes.

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Publication Date
Mon Jun 05 2023
Journal Name
Journal Of Economics And Administrative Sciences
The Effect of Knowledge Upgrading on Business Continuity:A Field Research in Private Colleges and Universities in Baghdad
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The research aims to study the effect of knowledge upgrade on business continuity in private colleges and universities in Baghdad. The research problem is summarized in the main question (were the academic leaders able to employ knowledge upgrading to enhance business continuity). The most important of this sector were the universities and the private college in the city of Baghdad as a field for this research, the researchers conducted a field visit to (10) universities or private colleges, the research sample consisted of (177) individuals from the deans of colleges and their assistants, as well as heads of scientific and administrative departments. The data was analyzed and the hypotheses were tested using the appropriate statistical

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