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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 May 15 2016
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
Population growth and the culture of consumption A field study in the city of Arbil.: Population growth and the culture of consumption A field study in the city of Arbil.
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research objectives to:
1. identify the social, economic and cultural factors affecting consumption.
2. detect the consumption culture among the population in the city of Erbil.
3. Identify the GATT consumer protection and rights.
The most important results:
1. that there is variation in the answers of respondents about keep up with modernity in the basic consumption (necessary), it swallowed the proportion of yes answers about keep up with modernity in food consumption (72%), and is an indication of growing consumer awareness of the individual in the side of nutrition. The clothing on the side of the proportion of yes answers amounted to (85%), in the health field note that the percentage of yes answers (83%), who are abr

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Publication Date
Sun Sep 03 2017
Journal Name
Baghdad Science Journal
Study of epidermis characters and venation of certain species of Medicago L. in Leguminosae (Fabaceae) family in Iraq
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The anatomical study of the epidermis leaflet for seven species and variety wild belonging to the genus Medicago L. species are: M. constricta Dur., M. coronata L., M. intertexta L., M. intertexta.var. ciliaris L., M. laciniata L., M. lupulina L., M. minima L. and M. sativa L. were studied, The search included epidermis characters and stomatal complexes addition to venation system in leaflets. It is revealed through the study, epidermis leaflet type Amphistomatic (the stomata spread on the upper and lower surface) as well as the presence of three types of stomatal complexes namely: Anisocytic (the guard cells surrounded by three unequal cell size), Anomocytic (not differential from subsidiary cells in epidermis) and Anomotetracytic (four ce

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Publication Date
Thu Jul 23 2020
Journal Name
مجلة العلوم النفسية
Influence of Model of Active Thinking in Achievement of Eighth Grade Students and their Visual Thinking in Science
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The aim of this study is to recognize the influence of model of active thinking in achievement ofeighth grade students andtheir visual thinking in science.The finds of this research show the superiority students of the experimental group who studied the science material by using the active thinking model on the students of the control group who studied by usual method, in the achievement test. Also the finds show that the students of the experimental group are more successful than students of control group in the test of visual thinking, so the two null hypotheses have been rejected. In light of the results of the research, numbers of recommendations were made.

Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
The study of physical and chemical properties of wells water in district of Samarra
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The Study was achieved adjectives physical and chemical water wells in the district of
Samarra , where a study has 42 sample groundwater in different regions of the judiciary
randomly distributed all over the judiciary and examined in vitro.
The study showed that the quality of groundwater in the general area of study
Kipritateh punctuated Klordih water quality and other quality Bicarboonatih.
Varied the key components of groundwater in the study area in concentrations
between periods of rain and drought, especially because of the cation ion exchange processes
as well as mitigation as a result of filtering rain water and dominated the calcium ion,
followed by sodium.
As for the negative ions has dominated ion s

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Publication Date
Mon May 01 2023
Journal Name
Journal Of Engineering
The Effect of Type of Fiber in Density and Splitting Tensile Strength of SIFCON
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SIFCON is characterized as a construction material of high ductility and very high strength. It is suitable for concrete structures used for special applications. However, the density of SIFCON is much higher than that of Fiber Reinforced Concrete (FRC) due to the need for a large amount of high-density steel fibers. This work examines the split tensile behavior of modified weight slurry infiltrated fiber concrete utilizing a mixture of two types of fibers, steel fiber, and polyolefin fiber. For the investigation, 30 cylinders and 15 cubes were poured. The used volume fraction (V.F) is (6 %) and the use of five series once as each type separately and once a hybrid in proportions of 2/3 polyolefin with 1/3 steel fiber and

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Publication Date
Thu Feb 01 2024
Journal Name
Baghdad Science Journal
Significance and Conservation of Birds of the Genus of Bee-eater (MEROPS) in Uzbekistan
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The purpose of this article is to identify and evaluate the importance of birds of the genus Merops (European Bee-eater -Merops apiaster and Blue-cheeked Bee-eater -Merops persicus) in Uzbekistan, as well as to develop recommendations aimed at solving some problems associated with its conservation. As a result of the study, in the aspect of biocenotic relations, the natural significance of these species was revealed. The economic value is determined and analyzed in beekeeping farms. From the study of the remains of food contained in the stomachs, throats and nests of M.apiaster, a preliminary list of the main species of the food spectrum has been compiled. Based on the bioacoustic repellent "Korshun-8"

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Publication Date
Sat Jan 31 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Oral health status, dental knowledge and behaviors among children and adolescents (8-15) years old in the cities of Baghdad and Thamar
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Background: Investigating dental health knowledge among children is important. Knowing what behaviors are right in relation to dental health does not guarantee that children will practice those behaviors. However, lack of knowledge and misconceptions about dental health may lead to behaviors that are harmful to teeth and gum. Baseline data on knowledge levels are required to determine which particular areas of dental health education are in need of improvement for high-risk children living in different geographical areas. This research was conducted to study the oral health status, dental knowledge and behavior in relation to two different cities, among children in Baghdad and Thamar (republic of Yemen) governorate. Materia

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Publication Date
Mon Jan 01 2018
Journal Name
Biochemical Cellular Archive
Immunological and molecular detection of herpes simplex virus type 1 and 2 in patients clinically diagnosed with parkinson’s disease and multiple sclerosis
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To determine the relationship between herpes simplex virus 1, 2 and neurological disorders, sixty samples from patients with neurological diseases were collected (40 patients with Multiple sclerosis and 20 patients with Parkinson’s disease) all of whom attended both the Neurological science Hospital as well as the Neuropathology consultation Department in Baghdad Hospital In Iraq. The samples were collected in the time frame between November 2017 and April 2018. The ages of the patients that were investigated were between (17-76) years and compared to a control group consisting of 25 samples collected from apparently healthy individuals. All the studied groups were subjected to the measurement of anti-HSV 1, 2 IgG antibodies by the means

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Publication Date
Tue Jun 28 2022
Journal Name
College Of Islamic Sciences
The impact of sins and disobedience on the individual and society in the Holy Quran objective study
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     The Noble Qur’an is the book of God, the Blessed and Exalted, in which is the teachings of God Almighty’s religion, which is Islam, in order for people to unite it and establish servitude to it. The individual and the society alike saw it appropriate to make my opinion alerting the seriousness of this matter, so the research was entitled (The Impact of Sins and Disobedience on the Individual and Society in the Holy Qur’an - Objective Study), knowing that we touched upon some of the effects, which we found it appropriate to mention in this research in the service of the good. Its details came in the Holy Qur’an without referring to others, noting their arrangement in the Holy Qur’an..

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Publication Date
Sat Jan 31 2026
Journal Name
Journal Of Physical Education
A study of some variables biomechanics in clean and jerk for the world champions men and women
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