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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 01 2013
Journal Name
Baghdad Science Journal
Assessment of Salivary and Serum Proteins in Patients with Oral Tumors
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The qualified subjects for this study included 33 patients with benign and malignant oral tumors aged 15-75 years and 31 matched age and gender healthy subjects used as control. Proteins measurements included total protein, albumin, globulines in sera and saliva samples, and immunoglobulins (IgG, IgM, IgA) in sera samples of control and patients. Meanwhile, polyacrylamide gel electrophoresis (PAGE) was used to differentiate between protein patterns in both serum and saliva samples among the studied groups. The gel was also stained for glycoprotein to evaluate as well the changes in glycoprotein contents. For total protein, the results revealed a signifigant increase (P?0.01) in both samples (serum and saliva) of patient group. Albumin conce

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Publication Date
Thu Feb 07 2013
Journal Name
Iraqi Journal Of Medical Science
A study of serum magnesium and calcium levels in missed abortion
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Publication Date
Wed Sep 01 2004
Journal Name
Faculty Of Engineering/mustansiriyah University
Studying and Analyzing Actual Safety Situation of Construction Factories in Iraq
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Safety programmes are considered one of the means to protect workers from different accidents and injuries and also to protect all assets including machines equipment and various materials. In spite of world state interests in occupational safety, this subject didn't get the required attention by senior staff of management at most of our country construction factories and the application of safety programmes still limited and in active. In order to a achieve the goal of the study, scientific method has been pursued to obtain the necessary information related to this study through tours to related companies and their construction factories and review literature that deal with occupational safety subject and their programmes and cost, in a

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Publication Date
Tue Mar 15 2022
Journal Name
Alustath
The Predicament of Youth in J D Salinger Franny and Zooey
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This research deals with Salinger's concerns about predicaments of youth like Franny and her brother Zooey. Their predicaments are related to identity, family, religion, beliefs, life and death, education, source of power, and society. It illustrates adults struggle to adapt themselves to live a normal social American life. It proves necessary to balance their coexistence in a materialistic milieu to achieve spiritual peace, tranquility, and stability.

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Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Study of total Immunoglobulin E and Eosinophil count in allergic disease
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The present study aimed to evaluate the levels of total immunoglobulin E and percentage count of eosinophil in some of allergic disease. Blood sample collected from 210 patients (110 female, 100 male) with allergic disease (allergic asthma, allergic rhinitis, and urticaria) their age between 10-70 years and 50 healthy control their age between 23-52 years. A highly significant (P<0.01) increase in the mean serum total IgE in patients with asthma (503.54 ± 63.49 IU/ml), Allergic rhinitis (442.77 ± 95.76 IU/ml) and urticaria (489.53 ± 69.68 IU/ml) as a compared with healthy controls (23.67 ± 5.81 IU/ml).There was a significant difference in percentage count of eosinophil in patients groups allergic asthma 4.37 ± 0.52% ,allergic rhinitis

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Publication Date
Mon Apr 24 2017
Journal Name
8th International Visible Conference On Educational Studies And Applied Linguistics
Woman’s Emotional Conflict and the Healing Power of Love in Nathaniel
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In Nathaniel Hawthorn's The Scarlet Letter, love and hate appear as independent powers that consume their holders. In this novel, Nathaniel Hawthorn presents a picture of the Puritans which shows an important part of American history. The Scarlet Letter outlines the American's brief moment of theocracy and extreme social order. Hawthorn is one of the first American writers to explore the hidden motivations of his characters. The Puritans wanted to establish an ideal community in America that can act as a model of influence for what they saw as a corrupted civil and religious order in England. This sense of mission is the core of their religious and social identity. That is why they required a strict moral regulation. The research tackles th

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Publication Date
Sat Apr 01 2017
Journal Name
1st Ijrtess – 2017 First International Conference On Recent Trends Of Engineering Sciences And Sustainability
Measuring Cohesion and Place Attachment of Selected Neighborhoods in Al-Adhamiya
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Historic centers are often subject to urban renewal without the prior knowledge of the extent of the cohesion and attachment to place of its inhabitants. Identifying the rates of cohesion and place attachment can help urban designers to avoid decisions that lead to clashes with the reality of the social groups inhabiting the neighborhoods of the historic center. So the research aimed to measure cohesion and place attachment in a methodological approach based on a psychological instrument conducted by previous studies .The measurements were applied through a questionnaire given to the residents of six elected neighborhoods forming the historic center of Al- Adhamiya.The research assumed the relative disparity rates of cohesion and place atta

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Publication Date
Thu Nov 17 2022
Journal Name
Journal Of Interdisciplinary Mathematics
The existence and uniqueness of common fixed points in expanded spaces
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Publication Date
Wed Aug 10 2022
Journal Name
Journal Of Positive School Psychology
The Need And Its Significance In The Novelist Discourse Of Naguib
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This study is at the heart of the pragmatic theory, as this research seeks to highlight the concept of necessity, and what the researchers have tended to do is that the development that has acquired integrated pragmatics is only for the development of the subject of necessity, as it is one of the contents of the saying, and this is what made Decroux define it as the semantic element that Concerning the saying, as for Grace; He paid great attention to the conversational imperative, and understood the requirement by clues or suggestions, as it is an element known for its absence and presence in the linguistic structures included in the text when reading or when understanding. This study has paved the way for clarifying the concept of necessi

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Publication Date
Mon Feb 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Variables yet and future help in the development of human resources
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 This research aims to study a range of yet and future variables that can affect human resources in Iraq and public organizations that influence the size of each, and the extent of its contribution to the development of human resources through the National Investment Commission of Baghdad. The identified research problem in a set of questions was the most important, what are the variables that help in the development of human resources to the Investment Commission of Baghdad theme of the search, in order to achieve the goal of research and answer questions about the problem, applied research on both the research community's (55) individual executives and employees.

 Researcher has identified a r

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