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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Feb 08 2022
Journal Name
Political Sciences Journal
The role of variables contact for non-state actors and opposite forces of civil social in ensuring the social peace
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Receipt date:6/3/2021  acceptance date:4/5/2021 Publication date:31/31/2021

Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License.

The research in the role of variables contact for non-state actors have become more influential in the current of contemporary events, that related with the reality of seeking services and providing all of that in favor of maintaining the social peace, and ensuring its empowerment in order to make peace and stability outcomes as a real fa

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Publication Date
Wed Aug 03 2022
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The role of the currency sale window in the stability of the dinar exchange rate and its reflection on inflation
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The: currency Auction is one of the monetary policy tools created after 2003, in order to keep pace with the changes that the monetary and financial policies will witness from financial openness and expectations of high levels of liquidity after international economic restrictions. It is necessary to re-evaluate the work of the currency Auction from time to time and observation its efficiency in adjustment the exchange rate And its reflection on the general level of prices as one of the objectives of its inception, and during the analytical aspect, it was confirmed that the currency Auction for selling the currency had a major role in adjustment the exchange rate and controlling inflation levels, due to the market’s dependence

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Publication Date
Mon Dec 27 2021
Journal Name
Palarch's Journal Of Archaeology Of Egypt/egyptology
The social and artistic connotations of the mural paintings of the Iraqi woman in the popular movement-an analytical study
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In the contemporary political history of Iraq, a unique protest broke out on October 1st, 2019. This protest reappeared on October 25th and lasted up to the following weeks making this protest as the most comprehensive and deepest one. It has the possibility of lengthening and the diversification of methods among all the social protesting movements during the century for Iraq. This desperate youth movement presents various images and methods to highlight the image of the protesting movement. The role of the Iraqi woman was clear, which was embodied through the mural paintings expressing her artistic and social role in conveying and expressing the goal of the protest. The aim of the current research is to identify the social artistic implica

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Publication Date
Wed Jun 19 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Impact of Self-Assessment on Income and Sale Tax Collection' From the Point View of Income Tax Auditors in Jordan
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This study aimed to show the extent of compliance with the income taxpayer  to provide tax returns and increase the speed of collection of these taxes in addition to increasing confidence in  Income Tax department and reduce the number of cases transferred to the courts and promote taxpayer awareness in charge of the importance of self-assessment system, and study sought to investigate the effect of the existence of records documents, technical audit, and computational audit and documentary audit on income tax collections in Jordan, from the point of viewof Jordanian income tax auditors ,results shows there's a strong  relation between these variables and Income Tax collections.

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Publication Date
Wed Jul 01 2020
Journal Name
Journal Of Environmental Engineering
Sustainable Use of Concrete Demolition Waste as Reactive Material in Permeable Barrier for Remediation of Groundwater: Batch and Continuous Study
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Publication Date
Thu Jan 02 2020
Journal Name
Journal Of The College Of Languages (jcl)
The composition of the vocabulary and passages in the poems of Saadi: بررسی ترکیب‌ سازی در قصاید و قطعات سعدی
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The importance of research and study of classical Persian literature is not overlooked.  So far, there have been many studies in this area.  But there are still some things that need more research.  Persian grammar is one of the most important branches of Persian literature.  This section has always been converted at different times.  One of the issues that has been neglected in the studies of classical literature is the study of the technical tales of past and past poetry.  These texts can be studied from different perspectives.  Because Persian is a mixed language, it is possible to combine language terms with each other or to add prefixes and suffixes to express new concepts. They can be used by exam

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Environment and lifestyle Fish Qattan in the Euphrates River in central Iraq
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Studied the environment and fish life Qattan in the Euphrates River in central Iraq for the period from September 2002 until 2003 recorded the lowest temperature of the water during the month of January during the month of August ranged salinity ranges between 068

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Publication Date
Mon Mar 12 2012
Journal Name
Iraqi Journal Of Science(the 1 St Scientific Conference Of Biology Department College Of Science University Of Baghdad March 2012)
Rotavirus Infection in Infants and Young Children with Acute Gastroenteritis in Baghdad.
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Publication Date
Mon Sep 30 2019
Journal Name
College Of Islamic Sciences
Scientific miracle in the verse walking and eating In Surat Al - Mulk
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The research includes the study of the scientific miracle in the verse: (It is the one who made you the earth humiliation and walked in their positions and eat from the living and to the publication of the human body and in the Qur'an) And mental and spiritual. The research also pointed to the tight link between the miracle of the precedent in the Holy Quran and the miracle of the divine power in the book of the Infinite Universe to give each miracle testimony of delivery and ratification of the other. The research included after the introduction, the first topic included four demands, which included basic concepts: - Definition of scientific miracle and its importance in the Koran, and the significance of the universal verses in the Kor

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