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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Nov 02 2014
Journal Name
Autophagy
Autophagy in osteoblasts is involved in mineralization and bone homeostasis
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Publication Date
Thu Jan 30 2014
Journal Name
Al-kindy College Medical Journal
Pulmonry function test in spinning and weaving workers in Iraq
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Background :The cotton factories have difference steps, spinning and weaving are van important parts of the factories. Cotton industry workers are exposed to various hazards in the different departments of textile factories. The major health problems associated with cotton dust are respiratory problems. Cotton workers display an excess of lung function abnormalities when compared to a community control population.
Aim of Study: This study assessed the effect of exposure to cotton dust in spinning and weaving workers on the lung function in Iraq, by measuring Forced Vital Capacity (FVC),Forced Expiratory Volume in the first second(FEV1), FEV1 ∕ FVC Ratio, and Forced Expiratory Flow 50%(FEF50%),with varying degree of reduction in lung

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Publication Date
Thu Feb 24 2022
Journal Name
Journal Of Educational And Psychological Researches
Analytical Study of the Content of Social and National Studies Textbooks of the Middle Stage in Kingdom of Saudi Arabia in the Light of the Values of Social Peace
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This study aimed to reveal the extent to which the values of social peace are included in the content of social and national studies textbooks of the middle stage in kingdom of Saudi Arabia. To achieve this goal, the researcher used the descriptive analytical approach. The study sample consisted of all developed social and national studies textbooks of the middle stage in kingdom of Saudi Arabia in first and second semester of student books in edition of 1439-1440. The study tool was the analysis card. The study reached the following results: 1-The content of social and national studies textbooks of the middle stage in kingdom of Saudi Arabia as a whole included (38) social peace values of total (40) values, corresponding to the inclusio

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Publication Date
Thu Jan 30 2014
Journal Name
Al-kindy College Medical Journal
Adenoid Hypertrophy in Adults and Nasal Obstruction
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Background .To know the incidence of adenoid hypertrophy in adults causing nasal obstruction and other nasal complains.
Methods.Prospective studyof(140 ) adult patientstheir main chief complaint were nasal obstruction , presented to Otolaryngology department at Aljumhory Teaching Hospital in Mosul , from the period (september 2010 to september 2011) ,their age ranged from (21 to 53) years . They were investigated clinically, radiologicaly ,and nasal endoscopic examination was carried out (rigid and fibro-optic ) . Adenoidectomy was performed for those with adenoid hypertrophy and sent for histopathological study .
Results:. we found adenoid enlargement in(24) patients (17.14%),in addition to nasalobstruction they were also complain

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Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Early Baldness in Males and Hormonal Changes
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Androgenetic alopecia (AGA) or baldness is a common form of hair loss, affecting men more than women .The exact causes and pathogenesis of baldness are not well understood. A search for new drug is still needed. This study aims to evaluate the role of gonadotropins hormones in hair loss in males and its possibility to be used as treatment target. A total of 78 volunteers 43 with baldness and 35 healthy men were participated in this study. Their age ranged between (20-49) years, the studied groups were divided into two categories: firstly according to age (group1: 20-29 year), (group2: 30-39 year),and (group3: 40-49 year).Secondly according to baldness degree. LH and FSH were measured by using Enzyme Linked Immunosorbent Assay (ELISA) kits.

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Publication Date
Thu Jun 30 2011
Journal Name
Al-kindy College Medical Journal
Asymptomatic Bacteriuria in Pregnant and Diabetic Women
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Background: Asymptomatic bacteriuria (ASB) is
defined as isolation of a specified quantitative count
of bacteria in an appropriately collected urine
specimen from an individual without symptoms or
signs of urinary tract infection.
Aim of study: To evaluate the frequency of
bacteriuria according to age, pregnancy, and type II
diabetes mellitus in a sample of Iraqi women.
Patients and Methods: A total of 125 female
individuals were involved. The study participants
were classified into the following groups: nonpregnant
women with type II diabetes mellitus,
pregnant women with type II diabetes mellitus,
pregnant women without type II diabetes mellitus, and
apparently healthy non-pregnant women. Urine

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Publication Date
Sun Jan 01 2012
Journal Name
Knowledge And Awareness Towards Cryptosporidiosis In Baghdad
Knowledge and awareness towards Cryptosporidiosis in Baghdad
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Knowledge and awareness towards cryptosporidiosis were assessed in this study during the period from April 2009 till June 2011, among 188 person of both gender which were divided in different groups and sub groups as following Group 1: include 48 physician from different hospitals and primary health care centers in Baghdad this group were sub divided into 30 Specialist doctors and 18 General practitioners doctors. Group 2 : include 45 teaching staff member from Biology department , Biotechnology department in University of Baghdad and AL-Nahrain University as well as teaching staff member from the college of medicine – University of Baghdad and University of Mustansiryah, this group were sub divided into 9 Ph.D and 36 M.Sc. + B.Sc. me

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Publication Date
Wed Jan 06 2021
Journal Name
Journal Of Planner And Development
Sustainable architecture and rural housing in Iraq
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Old Iraq includes the first experiences in establishing the first residential settlements in the Mesopotamian, and model villages designed and the pulp units in it and their natural matter, that made it perennial, and construction continues until now with it. These experiences were the basis for the emergence of the Iraqi civilization and thus the world and the beginning of writing, trade and the religions of the divine since before history, and then the Sumerian, Babylonian and Assyrian civilizations, and their villages that formed the Fertile Crescent.

There is a lack of knowledge and disregard for the distant and near history of Iraq in the field of rural housing, despite Iraq's leadership in this field, with the aim of the re

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Publication Date
Mon Feb 01 2016
Journal Name
2016 International Conference On Computing, Networking And Communications (icnc)
Connectivity and rendezvous in distributed DSA networks
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In this paper, we use concepts and results from percolation theory to investigate and characterize the effects of multi-channels on the connectivity of Dynamic Spectrum Access networks. In particular, we focus on the scenario where the secondary nodes have plenty of vacant channels to choose from-a phenomenon which we define as channel abundance. To cope with the existence of multi-channels, we use two types of rendezvous protocols: naive ones which do not guarantee a common channel and advanced ones which do. We show that, with more channel abundance, even with the use of either type of rendezvous protocol, it becomes difficult for two nodes to agree on a common channel, thereby potentially remaining invisible to each other. We model this

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Publication Date
Fri Apr 02 2021
Journal Name
Review Of International Geographical Education
Energy Security and Energy Transition in Germany
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Energy is one of the components of the national security of countries and is of particular importance to the industrialized countries, including Germany. Energy policy includes many areas and has an impact on various sectors such as the environment, climate, agriculture and others. During the past few years, Germany has witnessed many transformations, the most important of which is the energy transition towards renewable energy, and it was strengthened in the strategy that was It was developed in 2010, which aims to achieve a long-term energy transformation, and sales of the German energy technology sector have evolved from 2010 to 2020, and this issue is related on the other hand to the concept of energy security and because of its strateg

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