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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Apr 16 2024
Journal Name
International Development Planning Review
RESISTANCE TRAINING IN THE WEIGHT OF DIFFERENT BODY PARTS AND THEIR EFFECT ON SOME MECHANICAL BIO VARIABLES AND THE ACHIEVEMENT OF THE HIGH JUMP FOR YOUNG PEOPLE
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The study aims to identify the effect of training with weight added to different parts of the body in improving the biomechanical variables of the last step and upgrading the high jump for young people, the research was applied to one of the elite high jumpers for young people, and video imaging and kinetic analysis were conducted to extract the variables under study, and then the jumper underwent For the proposed exercises by 3 training units per week for a period of (8) weeks, in which emphasis was placed on improving the rotational forces (moments) of these parts, and then the post-tests were conducted, and the researcher concluded that the exercises applied and the added weights for all parts of the body (leg, thigh, trunk, and arms) le

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Publication Date
Wed Jun 29 2022
Journal Name
Baltic Journal Of Law & Politics
The Geomorphological Aspects in Diyala Governorate and the Possibility of Investing Them for Tourism Activity According to the Perspective of Sustainable Development Using RS and GIS Techniques
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Diyala Governorate has many unique and diverse geomorphological features that the region enjoys, which are among the attractions for natural tourism, as the natural environment is considered a maker of tourism. The importance of geomorphological aspects as components of natural tourism is due to their association with tourism and entertainment, as a result of the enjoyment of many geomorphological aspects of the beauty of its natural landscape on the one hand, and on the other hand, the association of these manifestations with different types of tourism activity. Any tourist area as it is the main factor for tourist attractions, such as the presence of the Hamrin hills, and sand dunes. Planning for the development of tourism activity in the

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Publication Date
Wed Mar 23 2022
Journal Name
Journal Of Educational And Psychological Researches
The Effectiveness of the (PEOE) Model in Teaching Science to Develop the Skills of Generating and Evaluating Information and the Scientific Sense among Intermediate First Grade Students
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The research aimed mainly to discover the effectiveness of the (PEOE) model in teaching science to develop the skills of generating and evaluating information and the emotional side of the scientific sense of the intermediate first grade students. An experimental approach with a quasi-experimental design called pre-test and post-test control design was used. The research sample consisted of (60) students, who were selected in a random cluster method, (30) students in the experimental group studied the unit "The Nature of Material" using the (PEOE) model, and (30) students in the control group studied according to the prevailing method of teaching. The research materials and tools were represented in: a teacher's guide for teaching the un

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Publication Date
Thu Feb 19 2026
Journal Name
Enterpreneurship Journal For Finance And Business
The role of psychological ownerships' dimensions in deterring the effects of toxic leadership: Analytical research in some companies at the Ministry of Industry and Minerals in Iraq
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Publication Date
Wed Jul 27 2022
Journal Name
International Journal Of Health Sciences
Detection of coxsackie virus B and measurement level of Tumor necrosis factor alpha in patients suffered in T1DM with coxsackie virus infection
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Objective. Infection with Coxsackie virus. This virus that damages pancreatic cells, has long been linked to the onset of insulin-dependent diabetic mellitus (IDDM). Pro-inflammatory cytokines can be produced as a result of this illness. Tumor necrosis factor-a is one of these pro-inflammatory cytokines. Materials and Methods. Blood sample were collected from 180 Iraqi participants. Ninety of them is type 1 diabetic patients and other 90 is healthy control .both groups were tested for the incidence of Coxsackie virus B IgG. So the patients groups is divided to two groups according to sero positivity of CVB-IgG .all 180 patients tested to measure of level of TNF-α. Results. The Results showed increasing in levels of TNF-α in CBV po

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Publication Date
Sun Mar 02 2008
Journal Name
Baghdad Science Journal
The Ability of Green Tea (Camellia sinensis) Extract in Modulating the Cytogenetic and Haematological Effects of Mitomycin C in Albino Male Mice
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The present study aimed to investigate the toxic and mutagenic and anti – mutagenic effects of the aqueous extract (5, 10 and 15 mg/kg) of green tea (Camellia sinensis) in modulating the genotoxic effects of mitomycin C (MMC). Albino male mice (Mus musculs) were employed as a biological system and four parameters were performed in vivo; total leucocyte count, mitotic index, chromosomal aberrations and micronucleus formation. The plant extract was evaluated through three types of treatments. In the first, the extract was given alone orally. While the second and third treatment included two types of interactions with MMC; pre – and post – MMC treatments. All treatments were paralleled by negative and positive control

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Publication Date
Sat Dec 01 2012
Journal Name
Iraqi Journal Of Physics
Power dissipation and time of breakdown in AC discharge of argon at a low pressure in the frequency range 5-10 kHz
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The influence of 5-10 kHz audio frequency on the power dissipation in ac discharge of argon gas was studied experimentally, at pressures 50-80 mTorr and electrodes separation 10 cm (pd range 0.5-0.8 Torr.
cm). The measurements have shown that the discharge behavior in the ac circuit is equivalent to a series RC circuit. It is observed that the variation curve of discharge power P with the frequency f is approximately has a Gaussian shape. It is also observed that the curve of Pm- pd is the inverse of Paschen curve, where Pm is the maximum power in the frequency range. The time of breakdown is estimated from the curve of P- f.

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Publication Date
Thu Feb 28 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The Impact of Adequacy and Authoritative Evidences in the Audit Risks: An Exploratory Research for A Sample Views of Auditors in Iraq
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The Audit evedances represent the reconciliation tools between the Financial data shown on financial statements, and the level of satisfaction level of the Auditor about these statements. According that, the Auditor try to achieve the highest quantity of These evidances, and the most satisfactive of it…, but that will be so hard sometimes, when the internal controlling system is not good, and when the Auditor had some satisfied evidences, but not sharp… So, this research comes to inspect the relation between the quantity, and the level of satisfaction, and argument to prove that evidences gives. This research assumes that getting enough evidences leads to reduce faults, improves the auditing operation, and avoids risks. The research

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Publication Date
Fri Apr 30 2021
Journal Name
Al-kindy College Medical Journal
Knowledge and Attitude of Family Doctors Regarding the Provision of Psychological Health Care in Primary Health Care Centers in Baghdad Al-Karkh
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Background: Mental health is integrated into PHC as a strategy of WHO to fill the gap in mental health treatment. Part of this strategy needs a level of task shifting so that mental health care is provided by different level of PHC workers and not only specialists such as psychiatrists and psychologists.

Objectives: To assess the knowledge and attitudes of family doctors regarding the provision of psychological health in PHCC and if there is an association between the certificates of these family doctors and their Knowledge and attitudes to psychological health.

Subjects and Methods:  A cross-sectional descriptive study with analytic elements was conducted in 8 famil

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Publication Date
Wed Mar 02 2022
Journal Name
Journal Of Educational And Psychological Researches
The Role of School Administration in Achieving Educational and Learning Goals as Seen by Educational Supervisors in the Stage of Basic Education
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This study aimed to identify the role of school administration in achieving educational and learning goals from the point of view of educational supervisors in the stage of basic education. The descriptive method was adopted. As for the sample size, it has reached (59) educational supervisors. A questionnaire consisting of 29 paragraphs divided into four areas was used. The data were statistically analyzed on the Chi-square test, the percentage, and the mono-variance analysis. The result showed that the school administration contributes to achieving educational goals. It also works to solve problems in democratic ways, and in modern methods, there are differences in the criteria for choosing the headmaster. The study recommended that sch

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