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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jul 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Using system dynamics model and the statistical indicators for Road Map of "Green government departments" project In Iraq
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Abstract                                                         

The issue of the protection of the environment is a shared responsibility between several destinations and sectors, and constitutes a main subject in which they can achieve sustainable development. In the sectors of government programs can be set up towards the establishment of the government sector to the green environment, so to be the implementati

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Publication Date
Tue Jun 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Financing and its impact on municipal performance in the municipalities of Missan governorate for the period (2011-2018)
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The research aims to show the role or extent of the impact of financing in its various forms on the municipal performance before and after the financial deficit through relying on the analytical research methodology of the research community represented by the Directorate General of Municipalities and the Directorate of Maysan municipalities as a sample of research (13) municipal institutions for a period of (8) years, Considering the completion of the final accounts of these years, which provides the necessary data for the study, in addition to the variation in the quality and amounts of grants allocated to municipal institutions during these years, which gives a clearer and more comprehensive picture of the reality of allocatio

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Publication Date
Fri Jan 11 2019
Journal Name
Iraqi Journal Of Physics
Determination the concentrations of radon gas and exhalation rate in some phosphate fertilizer using CR-39 track detector
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Publication Date
Sun Jul 20 2025
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Study and Investigation of the Charge Transfer Rate Production in N3-Senstized Dye Contact with ZnS Semiconductor System
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In this work, the rate of charge transfer (CT) reaction at the N3-ZnS interface was calculated using a quantitative computational model to evaluate the efficiency of N3-ZnS heterojunction dye-sensitized solar cell devices using different types of solvents. This work discussed the influence of the effective driving energy force on the charge transport rate and performance of N3-ZnS devices with various solvents based on a donor-acceptor model. A solar cell model was used to study the optical efficiency when changing some of its parameters, such as the type of material and the thickness of the film, as they are important factors influencing the quality of the solar cell. It was found that the transition energy varies with different so

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Publication Date
Sun Sep 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Using median rule in determining the establishment of service station between Al hasaka and Al kamishly serian cities
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Research indicates that the second half of the twentieth century marked large interests in the service industry by government and private organizations in that one, and the service industry has become the bedrock of plans in achieving economic and social development. From this standpoint felt specialists and researchers the importance of transport modes, including rail, which should be available between Almnltq Civil populated as services organized by the competent authorities to achieve the active participation of citizens in economic and social development in the region and that the term services means economic activities, which are the results Pollack concrete such as accepting the situation and satisfaction them or satisfacti

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Publication Date
Tue Jan 29 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Using Quality and Accreditation standard in performance improvement of education institutions: بحث تطبيقي في كلية الهندسة جامعة بغداد
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enjoyed the process of the development of higher education institutions attention of most countries of the world and to reconsider its objectives and programs and administrative and organizational structures, and it was the most important development of the application of Quality Assurance and Accreditation Standards (QAAS) tools, as the aim of these tools to the application of advanced with a far-reaching impact on all of the disciplines in the organization methods education that contribute, and plays a performance audit an important role in verifying the extent to which carried out these institutions activities or programs effectively and efficiently, economic, There are a number of objectives for the search of the most important attem

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Publication Date
Fri Mar 06 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
Building HEC-RAS model to detect the areas of Water Cycle Interruption in river stream and their sections
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The purpose of this paper is to build a simulation model by using HEC-RAS software to simulate the reality of water movement in the main river of Basra City (South of Iraq) which is known as Siraji-Khoura River. The main objective of the simulation is to detect areas where the water cycle is interrupted in some stations of the river stream, as this river has become an outlet for the disposal of sewage, leading to pollution and causing weakness in some sections of the river & obstructing the water cycle that takes place between this river and Shatt al – Arab river. A field survey data of the river and its banks were adopted to derive the grades, longitudinal and cross sections of the river, these data included three-dimensional coordinates

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Publication Date
Mon Feb 01 2016
Journal Name
Journal Of Engineering
Removal of Fluoride Ions from Wastewater Using Green and Blue-green Algae Biomass in a Fluidized Bed System
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The removal of fluoride ions from aqueous solution onto algal biomass as biosorbent in batch and continuous fluidized bed systems was studied. Batch system was used to study the effects of process parameters such as, pH (2-3.5), influent fluoride ions concentration (10- 50 mg/l), algal biomass dose (0–1.5 g/ 200 ml solution), to determine the best operating conditions. These conditions were pH=2.5, influent fluoride ions concentration= 10 mg/l, and algal biomass dose=3.5 mg/l. While, in continuous fluidized bed system, different operating conditions were used; flow rate (0.667- 0.800 l/min), bed depth (8-15 cm) corresponded to bed weight of (80- 150 g). The results show that the breakthrough time increases with the inc

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Publication Date
Wed Jan 30 2013
Journal Name
Al-kindy College Medical Journal
Incidence of Vertigo distribution among young adult and elderly in patients attending Al-Diwaniya Teaching Hospital . Al-Diwaniya.
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This study is prospective in nature, It consider
110 patients with vertigo who were assessed
between April and December 2010 at E.N.T out
patient department of otolarygiology, in Al
Diwania teaching hospital, in Diwania city,
Iraq. The study is designed to assess the
incidence of vestibular and non vestibular
vertigo and their association with
tinnitus,hearing loss,migraine in Young adult
and elderly.All patients were assessed by
questionary method and by pure tone
Audiometry.
Results: the incidence of vestibular vertigo was
69.1% while non vestibular vertigo is 30.9 %,
vestibular vertigo was inversely related to the
age while non vestibular vertigo directly related
to the age
The percen

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Publication Date
Sat Dec 01 2018
Journal Name
International Journal Of Entrepreneurship
The moderating effect of business environment on the relationship between entrepreneurial skills and small business performance in Iraq
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The purpose of this study is to examine the moderating role of business environment on the relationship between Entrepreneurial Skills (ES) and business performance of Small Business (SB) in Iraq, Baghdad. This study aims to resolve the inconsistencies found in the contemporary literature regarding the relationship between ES and business performance. Questionnaire using a 5-point Likert scale was adopted from previous work to ascertain the responses of the respondents. Survey research design was adopted, and self-administered questionnaires were used to collect the data from small business owners in 9 districts in Baghdad the capital of Iraq. The analysis was conducted using SPSS version 23.0. The direct relationship and hierarchical regre

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