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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Sep 03 2019
Journal Name
Biochem. Cell. Arch.
CHLAMYDIA PNEUMONIAE INFECTION AND ENDOTHELIAL DYSFUNCTION IN CARDIOVASCULAR DISEASES
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This study designed to evaluate the relationship between the Matrix metalloproteinase -9(MMP-9), soluble Vascular endothelial cadherin(VE-CAD)and Chlamydia pneumonia infection in cardiovascular diseases patients. All blood sample were subjected for molecular detection of C.pneumoniae by using conventional polymerase chain reaction (PCR) depending on 16S rRNA while the level of serum MMP-9, VE-CAD measured by enzyme linked immunosorbent assay (ELISA). Seventy patients who suffering from cardiovascular diseases (angina, myocardial infraction and atherosclerosis) aged between 33-86 years have been investigated and compared to twenty of apparently healthy individuals as control group. Twenty six samples (37.14%) revealed positive results for C.

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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
Political Culture and Civil Society in Algeria: Problematic relationship
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In light of what constitutes the cultural factor from a great importance in the context of the incorporation of an active and participant civil society in the process of democracy- building and the achievement of political development, this article tries to look at the concept of the political culture and the civil society with the stand on the nature of existing relationship between them in its theoretical part, then the move to dissection of the civil society crisis in Algeria under the prevalent cultural values for understanding the relationship between the two variables in its empirical part, as a step towards the detection on the pivoting of democratic values in activating the political participation and attainment the democratic co

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Publication Date
Wed Feb 05 2020
Journal Name
Political Sciences Journal
Populism in the Middle East: Discourse and Comparative Characteristics
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Abstract: The premise of the study is that populism is a process of building political views and critical intellectual orientations among the general public. It is transformed into mass beliefs by mobilizing the society ideologically and continuously in order to reach or control the circle of authority. We distributed the study topics to four sections: In the second, we will discuss the contents of contemporary populism and how other forms of populism evolved historically. The third is to discuss the political discourse of populism among the military regimes and the comparative Islamic parties in the Middle East, especially in terms of the essence and the intellectual foundations. The fourth section seeks to examine the characteristics o

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Publication Date
Tue May 16 2023
Journal Name
Political Sciences Journal
Educational Policies in Singapore and their Reflections on Development
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Singapore has invested its human resources for the development of the country since earlier times, so it has directed attention to the education sector. Education and development complement each other, as investment in education has contributed over several years to the development of Singapore economy and has made it one of the strongest economies in Asia and the world. Despite the obstacles that faced educational policies in Singapore, the presence of a wise leadership capable of overcoming difficulties and solving them, and providing the appropriate atmosphere for the development of education has contributed significantly to making it one of the most advanced educational systems in the world, and making this system the main pillar for

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Publication Date
Tue Mar 15 2022
Journal Name
Al-academy
Symbolic significance and its effectiveness in industrial product design
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The current research dealt with the symbolic significance and its effectiveness in the design of the industrial product, the aesthetic communicative discourse that embodies the imagination and human conscience. Whether according to what has been termed custom or what has been approved by traditions long ago, symbolism may be the main actor in linking the identifying components of the product. In addition, symbolism provides the user with the key to accessing a direct awareness of the product’s shape and function, as an identification of the product by stimulating the symbolic form of the consumer’s imagination and inviting him to To meditate in order to realize the implicit meaning behind these forms and thus achieve the symbolism of

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Publication Date
Tue Mar 05 2024
Journal Name
The Journal Of Obstetrics And Gynecology Of India
Obstetric and Neonatal Outcomes in Overweight Adolescent Pregnant Mothers
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Background The escalating global concern over increased body weight in adolescents, coupled with the rising rates of adolescent pregnancy worldwide, presents a significant challenge to healthcare systems. We plan to identify the maternal and neonatal consequences associated with pre-pregnancy overweight in adolescent women. Methods Throughout five years, all singleton adolescent pregnant women with pre-pregnancy self-reported body mass index (BMI) of 18.5– ≤ 29.9 were involved during the first-trimester visit. Two groups were generated: overweight and appropriate-weight (BMI 25–29.9 and 18.5–24.9, respectively). Obstetric and neonatal outcomes were observed prospectively and statistically adjusted for the confounding factors.

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Publication Date
Tue Feb 11 2025
Journal Name
Journal Of Ecohumanism
Climate Changes and Societal Stability in Iraq: Proposed Measures
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Iraq is considered one of the countries most susceptible to the negative impacts of climate change. According to international reports, it is classified as among the top five most affected by climate change in the world, leading to economic resource shortages and an increase in water scarcity, which exposes societal stability in Iraq to a threat.  This may result in social disintegration and civil conflicts, so climate changes are considered one of the most dangerous crises affecting societal stability in Iraq during this stage.  In this context, the research attempts to trace the causes of climate change and their effects on societal stability in Iraq and suggest some necessary measures to confront them in the future.  The resea

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Publication Date
Tue Mar 05 2024
Journal Name
The Journal Of Obstetrics And Gynecology Of India
Obstetric and Neonatal Outcomes in Overweight Adolescent Pregnant Mothers
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Background The escalating global concern over increased body weight in adolescents, coupled with the rising rates of adolescent pregnancy worldwide, presents a significant challenge to healthcare systems. We plan to identify the maternal and neonatal consequences associated with pre-pregnancy overweight in adolescent women. Methods Throughout five years, all singleton adolescent pregnant women with pre-pregnancy self-reported body mass index (BMI) of 18.5– ≤ 29.9 were involved during the first-trimester visit. Two groups were generated: overweight and appropriate-weight (BMI 25–29.9 and 18.5–24.9, respectively). Obstetric and neonatal outcomes were observed prospectively and statistically adjusted for the confounding factors.

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Publication Date
Sun Dec 16 2018
Journal Name
Al-academy
Sculptural Formation in the Third Millennium: Styles and Trends
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The research studies the sculptural formation in the third millennium: styles and trends, by taking the most important results of sculpture in the third millennium. The problem of the research is to search for the new sculptural formation in what it constitutes of social and human importance, and what are the important factors in forming the   contemporary sculptural structure, and what is the mechanism of showing and producing the new formation. The research requires the study of the most important thing that the (sculptural formation in the third millennium styles and trends) represents. The importance of research depends on the importance of the sculptural formation after the twentieth century and the importance that the for

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Publication Date
Wed Mar 15 2023
Journal Name
Al-academy
Active design and its principles in industrial product design
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 The problem of the research came through the following question (what is the effectiveness of active design in contemporary industrial products), and it emphasized the importance of research to make society with its members in a positive state of activity, and what can help the industrial product design to achieve this, but the goal of the study is (determining the characteristics and principles of design Active and its effectiveness in the industrial product), and the study was determined by industrial products related to daily, recreational and sports activity, The researcher relied on a form to determine the axes of analysis for the sample models, in order to reach the results of the research, the most important of which are: Realiz

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