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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Mar 18 2020
Journal Name
International Journal Of Research In Social Sciences And Humanities
THE EFFECT OF EXERCISE SPECIFIC TO USE DESIGNER (QUALITY RESPONSE) DEVICE TO DEVELOP THE SPEED AND ACCURACY OF THE RECEPTION AND PASSING SKILLS OF FOOTBALL PLAYERS IN AGES (14 YEARS)
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Publication Date
Tue Jun 15 2021
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Effects of Exclusive Breast Feeding for First Six Months of life on Children Weight, Height and Head Circumference in Sulaimani City, Kurdistan-Iraq and Compare with Other Types of Feeding
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Breastfeeding (BF) serves as a complete nutritional source for the first six months of infant’s life. Breast milk contains all essential nutrients that necessary for the physiological growth and development of infants. The aim of this study was to compare the physiological growth of infants including weight, height and head circumference who were exclusively breastfed for 6 months and those who were given bottle-fed or mixed fed and to find a percentage of exclusive breastfeeding among mothers who contributed in this study in Sulaimani city. This study was carried out in Sulaimani city/ Kurdistan region of Iraq and the cases were enrolled between the first of October 2018 and first of October 2019. The infants’ weight, height and hea

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Publication Date
Sat Feb 02 2019
Journal Name
Journal Of The College Of Education For Women
The Balance and unbalance in alliance relations The Saudi Arabia and United State Relation as model: The Balance and unbalance in alliance relations The Saudi Arabia and United State Relation as model
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Abstract:
Saudi Arabia and United States long relation could present an important
subject to understand alliance kind in international relations types. We trying
in this study to diagnose and analyze the Saudi Arabia and United States
model to find balance and unbalance statues and its influence on the
directions of Saudi Arabia foreign policy positions.
We divided the study in two parts, each part have many sections. The
first part deal with the historian emergence of Saudi Arabia state and its
development in three stages including its foreign relations with regions and
international powers. While the second part was dedicated in analyzing and
understanding the mechanism and active facts that drawing the Sa

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Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
Al-Rawandi and His Book “Rahat Il-Sudoor and Ayat Il-Suroor” A historical Study in Content and Style
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The Rwandan author of comfort chests and verse pleasure of the most important historians of the Seljuks in the sixth century AH / twelfth century and belongs to the mostly ethnic scientists family has won favor with the Sultans of the Seljuks until he became the most famous Markhém is his main source of research sources with respect to the political and social history the Seljuks and the relationship of the Seljuk sultans of the Abbasid caliphs in Baghdad.
The book included the history of the Seljuks from the time of statehood in the fifth century AH / atheist century AD until the death of the Sultan Tgrl bin Arslan year 590 AH / 1193 AD and then shed Akhawarzmeyen, and touched the author at the end of the book in separate chapters t

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Publication Date
Thu Nov 08 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Macrovascular and microvascular complications in type 2 diabetic Iraqi patients treated by metformin and glibenclamide versus metformin and sitagliptin
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Background: In type 2 diabetes mellitus there is a progressive loss of beta cell function. One new
approach yielding promising results is the use of the orally active dipeptidyl peptidase-4 (DPP-4)
inhibitors for type 2 diabetes mellitus.
Objective: This study aims at comparing the possible occurrence of macrovascular & microvascular
complications in Iraqis patients with type 2 diabetes mellitus using two combinations of drugs
metformin + glibenclamide and metformin + sitagliptin.
Methodology: Sixty eight T2DM patients and 34 normal healthy individuals as control group were
enrolled in this study and categorized in to two treatment groups. The group 1 (34 patients ) received
metformin 500 mg three times daily

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Publication Date
Thu Jun 30 2022
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
STUDY OF SOME GROWTH CRITERIA AND YIELD OF SOYBEAN CROP WITH THE EFFECT OF BORON AND SOME GROWTH REGULATORS: STUDY OF SOME GROWTH CRITERIA AND YIELD OF SOYBEAN CROP WITH THE EFFECT OF BORON AND SOME GROWTH REGULATORS
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The study was conducted at research station A, department of field crops, college of agricultural engineering sciences, university of Baghdad during summer 2021 to evaluate the effect of boron and some growth regulators on some growth criteria and yield of soybean crop (cv. shimaa). The experiment  was carried out according to split plots by using randomized complete block design with three replications. The main plots included three concentrations of boron (75, 150 and 225) mg.L-1, the sub-plots included three levels of growth regulators, spraying kinetin (100 mg. L-1), spraying ethrel (200 mg.L-1) and spraying kinetin (100 mg.L-1) + spraying ethrel (200 mg.L-1) as

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Publication Date
Sun Dec 01 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Governance and role in increasing the tax outlet in Iraq
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The goal of the research is to highlight the role of the governance and its characteristics in increasing the tax outcome by implementing the laws, regulations and annual controls issued annually from the general authority for taxation for the financing of the general treasury of the state, Additional development and economic capacity, As the search shares a view of the governance and its characteristics and its ideas from increasing tax output. The analytical transparent approach was used by adopting the practice of practicalities of the general authority for tax For quotations in the senior cabinet section ,the revealing of the ongoing operations was relied on the revenue for each financial year, The tools adopted in the process of ana

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Publication Date
Tue Apr 14 2015
Journal Name
Merit Research Journal Of Agricultural Science And Soil Sciences
Heavy metals pollution in soil and its influence in Iraq
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Soil is a crucial component of environment. Total soil analysis may give information about possible enrichment of the soil with heavy metals. Heavy metals, potentially contaminate soils, may have been dumped on the ground. chromium, nickel and cadmium,

Publication Date
Sat Jul 29 2023
Journal Name
International Journal Of Professional Studies
MULTIMODALITY IN THE COURTROOM IN AMERICAN AND BRITISH CRIMINAL CASES
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PDBN Rashid, International Journal of Professional Studies, 2023

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Publication Date
Tue Jun 14 2016
Journal Name
Al-academy
Figure role in highlighting and content in the technical poster
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The poster is one of the means which can be communicate with others through it, to transfer ideas that the designer want to focus on, for its importance to accomplish the poster. It’s a visual mean contact aim to submit an idea to the audience to get a clear idea, and that would be through the shapes and subject to submit the idea. Depend on that our goal in this study is to find out, what follows:1-Finding the relationship between the shape and the idea.And the study comes up with several results, like:1-The drawings that contain themes connected with what the designer want to achieve, through the clearness of idea and to make those elements clear by putting more elements to surround the main shape.2-To assure that the strong connecti

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