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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Nov 01 2016
Journal Name
Philological Sciences. Scientific Essays Of Higher Education
Principles of phono-grammar in the annex to progressive categorazation of Arabic and Russian roots
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Publication Date
Fri Mar 19 2021
Journal Name
Plant Archives 21 (1), 1463-1469‏
Effect of addition of organic fertilizer and rootstock in Lemon transplants exposed to water stress‏
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Publication Date
Tue Jan 01 2019
Journal Name
International Journal Of Nursing Education Scholarship
Validity and Reliability of the Arabic Version of the Incivility in Nursing Education-Revised Scale
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Abstract<sec id="j_ijnes-2019-0074_s_001a_w2aab3b7c96b1b6b1aab1c14b1Aa"><title>Background

Incivility in nursing education can negatively affect the academic achievement. As there is no tool in Arabic to assess incivility among nursing students, there is a need for a valid and reliable tool.

Purpose

This study aimed to investigate the psychometric properties of the Arabic version of the Incivility in Nursing Education- Revised (INE-R) survey.

Method

Th

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Publication Date
Wed Dec 23 2020
Journal Name
Iraqi Journal Of Agricultural Sciences
THE TAXONOMICAL SIGNIFICANT OF COMPUTERD PHYLOGENETIC ANALYSIS AND MORPHOLOGICAL DATA IN SOME SPECIES OF POLYGONACEAE
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This research dealt with study of cladistics taxonomy of  five  species related to the genus Rumex L. and Polygonum L. from family polygonaceae in Iraq by using Mesquite software V.2.75. This  research support strongly delimiting  the species P. aviculare L. and P. lapathifolia L.as suggested in floras publication while R. dentatus L. is setted in single group whereas R. vesicarius L. and R. conglomeratus Murray were included in the same group. Also, this study involved characteristics of shape, dimensions, color, and ornamentation of seeds and fruits as  the seed forms were ranging from lenticular to trigonous. In terms of size calculations,  the seeds of R. vesicarius  was recorded the higher range (4.0- 4.5) mm in length w

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Publication Date
Tue Mar 01 2011
Journal Name
Journal Of Economics And Administrative Sciences
Measurement and analysis of the production function of the transport sector in the Iraqi economy
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Transportation Sector classified as one of the services sectors which is without the production activities cannot be complete its rule. Is act asmoving actions which operate at production and non production goals for the organization and individuals insides the country and with others, that is why this sector act as one of the main which is occupied an important status on the way the economic activities and on the level of the economic institutions the transportation work on transforming all the commodities and products from productions locations to consumption location then its effect the productivity process and create the location utility and on the level of economic it considered as one of the economic supportive structure an

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Publication Date
Sun Aug 18 2019
Journal Name
Political Sciences Journal
Strategic dimensions of the Turkish role in the map of international and regional forces balances
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It is necessary to examine the nature of the Turkish position and what Turkey seeks to achieve at the international, regional and Iraqi levels. Or is this external role an expression of foreign policy and has not yet reached the level of maturity that reaches the stage of strategy? The answer to this question is the essence of research in the Turkish role. The answer to this question requires the realization of the elements and pillars that guarantee Turkey's continuity and survival. Continuity is a cornerstone of the strategy. The continuity of the role and its interaction with the event and the ability to employ multiple alternatives are what qualify the state to describe its politics. The external strategy has evolved into. In order t

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Publication Date
Sun Jan 01 2023
Journal Name
Dental Hypotheses
Assessment of Elongation Percentage, Tensile, and Tear Strength of Filler Particles: An In Vitro Study
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Publication Date
Thu Dec 13 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Evaluation of Women's Knowledge and Personal Preference about The Place of Delivery in Baghdad City
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Objective: The study aim to evaluate of women's knowledge and personal preference about the place
of delivery in Baghdad City
Methodology:
descriptive study conducted in baghdad city on the mothers for the period from the 14th of December,
2015 to the 14th of April 2016. The sample of study included 500 mothers who were attending to
primary health care centers have been chosen sample of 26 primary health care center by a multi-stage
Simple random sampling Data was collected through a constructed questionnaire, validity Data was
analyzed by using of descriptive and inferential data analysis methods .
Results: The results indicated that approximately (29.4%) of the mothers in the age group (20-24) and
the average

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Publication Date
Sun Jan 01 2023
Journal Name
Revista Iberoamericana De Psicología Del Ejercicio Y El Deporte
EXPLORING THE MODELING OF SOCIO-TECHNICAL SYSTEMS IN THE FIELDS OF SPORT, ENGINEERING AND ECONOMICS
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Publication Date
Fri May 01 2020
Journal Name
Indonesian Journal Of Electrical Engineering And Computer Science
Smart grid in the context of industry 4.0: an overview of communications technologies and challenges
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The recent advances in technology, the increased dependence on electrical energy and the emergence of the fourth industrial revolution (Industry 4.0) were all factors in the increased need for smart, efficient and reliable energy systems. This introduced the concept of the Smart Grid (SG). A SG is a potential replacement for older power grids, capable of adapting and distributing energy based on demand. SG systems are complex. They combine various components and have high requirements for real time reliable operation. This paper attempts to provide an overview of SG systems, by outlining SG architecture and various components. It also introduces communication technologies, integration and network management tools that are involved in SG sys

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Scopus (44)
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