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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Mar 13 2026
Journal Name
Journal Of The College Of Basic Education
The impact of cross-training in the development of the skills of the crushing blow and the blow-to-blow stroke under the age of 17
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Publication Date
Sat Jun 01 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Rationalization the costs and improve seed quality under the application of biotechnology: An Applied Research in Ministry of Agriculture - the Directorate of Inspection &Certification of Seeds
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The importance of this research has been to rationalize the cost of producing maize seeds through the followers of modern techniques and methods in agricultural activities such as genetic engineering for the purpose of increasing production efficiency of maize seeds as well as the importance of calculating seed cost rationalization through the ABC system and thus rationalizing government spending. The research is based on a single hypothesis that the use of genetic engineering on corn seeds works to:increase production efficiency of seeds and savings in agricultural inputs, calculation of rationalization through the cost system on the basis of activity ABC The research reached a number of conclus

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Publication Date
Mon Sep 08 2025
Journal Name
Retos
The effect of mental training for sensory perceptions of skill performance in some indicators of electrical activity and the special physical abilities of young pole vaulters
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Objective: The aim of the research is to prepare skilled mental exercises according to spatial and temporal perceptions and the awareness of the strength of young pole-vaulters, and to recognize the impact of these exercises on improving the indicators of electrical activity of working muscles and some special physical abilities and accomplishing this effectiveness Research methodology: The researcher used the experimental curriculum (one experimental group), and included the sample of research on (5) two joint jumpers in the Iraqi club championship, all from the center of talent in athletics, the sample is trained on the same curriculum prepared by the coach himself but accompanied by a mental training approach that Prepared by the

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Publication Date
Fri Apr 12 2019
Journal Name
Journal Of Economics And Administrative Sciences
Transformational leadership and its role in organizational success An analytical study of the views of a sample of employees at the Faculty of Education, Samarra University
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This research aims to know the role of transformational leadership in the organizational success of the College of Education at Samarra University. The researcher adopted the analytical descriptive method in analyzing the research problem. The research included two main hypotheses that resulted in four hypotheses that were subjected to statistical tests. A sample of (54) The researcher used the survey method as a main tool for collecting data and information as well as visits and structured interviews that took place during the period of application. The research reached a set of conclusions and recommendations among the conclusions that there is an art relationship There is a strong and moral impact between transformational lead

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Publication Date
Wed Jul 01 2015
Journal Name
Journal Of Educational And Psychological Researches
The impact of discrete realization strategy in the development of reflective thinking among students of Qur'an and Islamic education departments for the course of Islamic jurisprudence
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The paper aims to identify the impact of discrete realization strategy in the development of reflective thinking among students: (males/females) of Qur'an and Islamic education departments for the course of Islamic jurisprudence according to the variability of sex. The researcher used the experimental approach and adopted an experimental determination with a set part of the two groups (experimental and controlled). He selected the sample deliberately which consists of (147) students spread over four classes (experimental males/ experimental females/ controlled males/ controlled females), and it took last for an academic year of (2010-2011). He, then, prepared a post test to measure the reflective thinking with his five skills (skill of o

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Publication Date
Mon Oct 20 2025
Journal Name
Научный форум
Strategies of cultural adaptation and linguistic russification in the muravyov-kistyakovsky translation of 'the fellowship of the ring' (1982): a comprehensive study of fantasy text domestication
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This study examines strategies of cultural domestication in Muravyov and Kistyakovsky’s Russian translation of (The Fellowship of the Ring). It documents transformations of character names, toponyms, dialogues, and cultural references, highlighting systematic Russification and the infusion of Soviet political commentary that reshape the text into cultural rewriting.

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Publication Date
Wed Feb 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
Strategic Command and its role in activating the Organisational performance analytical study of the views of the heads of academic departments at General Authority of groundwater.
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Abstract

The research aims to identify the strategic leadership and its role in activating the Organisational Performance, which is an analytical study of the views of the heads of scientific departments at General Authority of groundwater researcher's quest focused towards building a theoretical framework suitable for strategic leadership and performance Organisational and itُs dimensions.To achieve the aims of the research is designed to identify the researcher included (35) items to collect the raw data from the research sample consisting of 33 of the heads of departments. Data was collected by questionnaire, field visits, interviews and some official documents to complete the search data. It has also been used a numb

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Publication Date
Tue Feb 01 2022
Journal Name
Baghdad Science Journal
Association of Endothelin-I and A symmetric Dimethylarginine Levels with Insulin Resistance in Type-2 Diabetes Mellitus Patients
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Endothelin-I (ET-I) is one of the potent vasoconstrictors secreted from endothelial cells when needed. Many studies revealed the elevation of serum ET-I with human diabetes and microangiopathies. Since insulin resistance is a case of mixed diabetic and pre-diabetic cases, many risk factors beyond obesity and inflammation are proposed. The current study aims to demonstrate the association between serum ET-I and asymmetric dimethylarginine (ADMA) and insulin resistance in type 2 diabetes mellitus (T2DM). Sera of 73 subjects were enrolled currently (control= 35 subjects, and 38 with T2DM for more than 7 years), aged (40-60) years old, with distinct body mass index (BMI) ≤ 25 for control volunteers and (BMI) ≥ 25 for obesity and diabetes

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Publication Date
Tue Dec 31 2024
Journal Name
Journal Of Emergency Medicine, Trauma And Acute Care
Flow cytometric estimation of low-density neutrophil antibody labeled and non-labeled phagocytosis assay in patients with periodontitis
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Background: Neutrophils destroy pathogens via phagocytosis. Neutrophils are effective innate and acquired immunity phagocytes. Low-density neutrophils are distinct neutrophil phenotypes linked to several systemic and infectious diseases. To our knowledge, low-density neutrophil phagocytosis in periodontitis has not been examined. Opsonized and non-opsonized fluorescent beads mixed with low-density neutrophils were gated and analyzed by flow cytometry to count cells that consumed at least one bead.

Aims of the Study: To estimate the potential impact of antibody (Ab)-labeled and non-labeled phagocytosis capacity of low-d

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Publication Date
Mon Jan 01 2018
Journal Name
Al-mustansiriyah Journal Of Science
Relationship of Obesity to Serum Ferritin, Lipid Profile, uric acid and urea at Obesity Medical Center in Iraq
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