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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Feb 01 2014
Journal Name
World Journal Of Pharmaceutical Sciences
Detection of JAK2V617F Mutation and Serum Levels of Alkaline Phosphatase and Lactate Dehydrogenase in Chronic Myelogenous Leukemia.
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Chronic myelogenous leukemia (CML) is a myeloproliferative neoplasm arises from Bcr-Abl gene translocation (called Ph chromosome) in hematopoietic stem cells (HSCs). This genetic abnormality results in constitutive activation of tyrosine kinase and subsequent uncontrol growth and multiplication of granulocytes. The cornerstone in treatment of CML are tyrosine kinase inhibitors, of which imatinib is the most effectively used. JAK2V617F mutation is an acquired single nucleotide polymorphism (SNP) occurs in JAK2 gene and is associated with many hematological malignancy other than CML. It was thought that the two genetic abnormalities (Bcr-Abl and JAK2V617F) occur mutually; however, growing body of evidences suggested the reverse. This study a

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Publication Date
Tue May 16 2023
Journal Name
Political Sciences Journal
Public Rights and Freedoms in the Constitution of the Sultanate of Oman and Ways to Protect Them
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What distinguishes human rights issues is their importance to the international community and their importance to democratic political regimes, because they are the axis of any political regime that seeks to achieve a successful democratic path and a stable state. So, countries that are interested in human rights try to enshrine those rights and freedoms in their constitutions and reinforce their concepts in their laws and legislations. Not to mention its involvement in international conventions and treaties concerned with human rights and freedoms, and this is what the Sultanate of Oman has worked on and confirm in the provisions of its 1996 constitution and its amendments

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Publication Date
Wed Jan 03 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Proficiency and Knowledge of Community Pharmacists in the Use of Liraglutide and Semaglutide as Weight Reduction Agents
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Background: In recent years, the prevalence of obesity has climbed sharply. Still, only a few safe and effective medications are approved as weight-loss drugs. Objective: This study aims to assess the knowledge and practice of community pharmacists in Iraq regarding the use of Liraglutide and Semaglutide as weight-loss medications. Method: A cross-sectional survey was implemented using a validated questionnaire and a convenient sample of Iraqi community pharmacists from different governorates. The questionnaire was created after conducting a literature review of the most important articles about liraglutide and semaglutide. The questionnaire consists of three sections. The first part was used to collect demographic information. The second a

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Publication Date
Fri Dec 01 2023
Journal Name
Baghdad Science Journal
Effect of COVID-19 on the Role of Renin Enzyme and ACE2 and Hormones in PCOS Females
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Polycystic ovary syndrome (PCOS) is the most endocrine problem in women of regenerative age. PCOS women typically belong to an age and sex group which is at higher risk for severe coronavirus disease (COVID-19). COVID-19 targets cells through angiotensin-converting enzyme 2 (ACE2) receptor presents on cells in veins, lungs, heart, digestion tracts, and kidneys. Renin-Angiotensin System (RAS) over activity has likewise been described in metabolic disorders; type 2 diabetes mellitus (T2DM), and conditions shared by women with polycystic ovary condition. The point of this study is to know the job of renin and ACE2 in PCOS and coronavirus and its relationship with hormones and other metabolic parameters related. The study groups consist of 1

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Publication Date
Sun Oct 21 2018
Journal Name
Al–bahith Al–a'alami
Islamic Knowledge and its role in the Development of the Culture and Values of the Islamic Community
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The human perception of science and knowledge is affected by the personal point of view, thus giving it its religious, mental and emotional dimensions to make that perception an effective tool for realizing the truth comprehensively in the delivery of knowledge to the depths of the human soul. The later is composed of multiple factors, which contributes to the human self-development with dimensions beyond the limits of mental logic and the perception of material and emotional situations. That knowledge in the perception of Islamic virtue, which must characterize each Muslim.
Human beings have been striving for knowledge and the understanding of the universe in which they live. For centuries, mankind has acquired knowledge directly an

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Publication Date
Mon Jan 01 2018
Journal Name
Research Journal Of Pharmacy And Technology
Estimation of Alkaline Phosphatase level in the Serum and Saliva of Hypothyroid Patients with and without Periodontitis
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Publication Date
Sun Nov 01 2020
Journal Name
Journal Of Physics: Conference Series
Purification of Leucine aminopeptidase and its correlation with biochemical parameters in sera of subclinical hypothyroidism and hypothyroidism
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Publication Date
Tue Jan 27 2026
Journal Name
Al-adab Journal
Western Hermeneutics and Heritage: A Contemporary Study in the Debate of Understanding and Horizon.
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Publication Date
Tue Jan 01 2019
Journal Name
Energy Procedia
Humidity effect on diffusion and length coefficient of radon in soil and building materials
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Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
African landlocked countries problems and outlets in the study and classification of geo-political
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Landlocked countries are displayed geopolitical new geo-political and intended to
countries that do not have sea views, a phenomenon present in four continents of the world
are: Africa, Europe, and Asia, and South America and the number arrived at the present time
to the (44) state the largest number of them in the continent it arrived in Africa (16) countries
in Asia (13) countries and Europe (13) In the State of South America two. This phenomenon
emerged due to the division of federations and empires and colonial treaties and others. But
the negative effects suffered by these countries may vary from one country to another, since
these countries in the continent of Europe, for example, is different from the same cou

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