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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Dec 30 2024
Journal Name
مجلة الكوفة للعلوم القانونية والسياسية
MANIPULATION OF SOFT POWER IN THE US COMPREHENSIVE STRATEGY TOWARDS FRANCE AFTER 2001
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Although the events of September 2001 marked the United States' employment of solid forces in its direct comprehensive strategy to counter terrorist organizations and any other challenges to US national security, the United States did not lose sight of the importance of the cultural variable. The cultural variable is the United States' most important instrument of soft power in ensuring its dominance of the international system and promoting its global project. France viewed US soft power as a threat to its own civilizational pattern. Therefore, France considers culture to be an inherent component of its national personality and a cornerstone of its international standing as a major force. Additionally, the US-French political and economic

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Publication Date
Sat Oct 01 2022
Journal Name
Baltic Journal Of Law & Politics
The position of Iraq in Russia's foreign policy after the year 2000 AD
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This research deals with the foreign policy and the Russian trends towards Iraqafter the year 2000 AD, the international variables that affect that bilateralrelationship and the importance of the position and weight of Iraq in the MiddleEast and the attempt to include Iraq in the international organizations and blocsled by China and the Russian Federation such as the Shanghai CooperationOrganization, and joining the Chinese Belt and Road project to serve interests TheIraqi economy, and an attempt to extend its influence through security alliances inthe region in general, and Iraq in particular, as the quadrilateral center of the waron terrorism in which Russia, Iran, Iraq and Syria participated, which strengthensbilateral relations between

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Publication Date
Tue Mar 19 2019
Journal Name
Political Sciences Journal
Rentierism effect on the democratic choice of the state In Iraq after 2003
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The linguistic meaning of the verse in the Arabic dictionaries applies very much to the reality of rent and its effect. This is true of economic growth as a continuous increase in real per capita income in addition to the same thing. Therefore, development does not necessarily achieve a comprehensive and structural increase of the various economic sectors. As the rent came in the sense of a terrible land open Maim any fertilized. And the camel is a ma'aya and a ra'i: that is, it goes in the pasture and returns itself. This is similar to the extraction of oil after it is ready for investment and earn its revenue as soon as it exists or is extracted by external parties. If the rent is first linked to agriculture, especially the fertile lan

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Effect of spraying fertilizer paper and aqueous extract of licorice in the content of the fruits of two varieties of sweet peppers total Azaúbh solids and vitamin
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Studied the effect of foliar fertilizers Alaongrin results showed that spraying fertilizer Alaongrin and Fertilizers and Ministry of Agriculture and rack licorice extract every three weeks after thirty days from planting seedlings

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Publication Date
Mon Feb 04 2019
Journal Name
Journal Of The College Of Education For Women
Iraqi-Saudi Relations After 2003
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Iraqi-Saudi Relations have witnessed a state of rapprochement over decades. However, this rapprochement was temporary and could not overcome the differences that formed the core of Iraqi-Saudi relations after 2003, relations between Iraq and Saudi Arabia deteriorated with the Iraqi governments that followed the rule of Iraq after 2003, especially the government of Nuri Al-Maliki in which relations reached the end of mutual accusations between the two parties. In order to promote the relationship between the two countries, a culture of moderation has to be propagated especially in the field of religion and the religious institution should be encouraged to open up to other sects and to recognize all sects as prelude to combating the cultur

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Publication Date
Fri Dec 19 2014
Journal Name
Mutagenesis
Assessment of oxidative damage to DNA, transcriptional expression of key genes, lipid peroxidation and histopathological changes in carp Cyprinus carpio L. following exposure to chronic hypoxic and subsequent recovery in normoxic conditions
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In fish, a complex set of mechanisms deal with environmental stresses including hypoxia. In order to probe the hypothesis that hypoxia-induced stress could be manifested in varieties of pathways, a model species, mirror carp (Cyprinus carpio), were chronically exposed to hypoxic condition (dissolved oxygen level: 1.80±0.6mg/l) for 21 days and subsequently allowed to recover under normoxic condition (dissolved oxygen level: 8.2±0.5mg/l) for 7 days. At the end of these exposure periods, an integrated approach was applied to evaluate several endpoints at different levels of biological organisation. These included determination of (i) oxidative damage to DNA in erythrocytes (using modified comet assay), (ii) lipid peroxidation in liver sample

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Publication Date
Wed Feb 01 2023
Journal Name
Petroleum Science And Technology
Lithofacies and electrofacies models for Mishrif Formation in West Qurna oilfield, Southern Iraq by deterministic and stochastic methods (comparison and analyzing)
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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Molecular Typing of Two Suspected Cutaneous Leishmaniasis Isolates in Baghdad
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Leishmaniasis is a group of parasitic diseases caused by Leishmania spp., an endemic infectious agent in developing countries, including Iraq. Diagnosis of cutaneous lesion by stained smears, serology or histopathology are inaccurate and unable to detect the species of Leishmania. Here, two molecular typing methods were examined to identify the promastigotes of suspected cutaneous leishmaniasis samples, on a species level. The first was species-specific B6-PCR and the second was ITS1-PCR followed by restriction fragment length polymorphism (RFLP) using restriction enzyme HaeIII. DNA was extracted from in vitro promastigote culture followed by amplification of kDNA by B6 or amplification and digestion of LITSR/L

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Publication Date
Thu Sep 01 2016
Journal Name
J Bagh College Dentistry
Comparison of Immunoglobulin IgA level in the stimulated saliva of caries-free and caries-active children aged 7-10 year
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Background: Salivary immunoglobulin IgA plays an essential role in the immune response against dental caries. This studywas conducted to compare the salivary IgA levels and flow rate of stimulated saliva in caries active and caries free children. Materials and methods: The present study included sixty healthy children age 7-10 yearswho were divided into two groups. They were caries free and caries active children (30 children in each group). Assessment and recording of caries – experience were through the application of Decayed, Missing and Filled Tooth Index (DMFT) and (dmft) index, for permanent and deciduous teeth respectively. After dental examination, stimulated saliva samples were collected from the subjects and performed und

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Publication Date
Wed Sep 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Immunoglobulin IgA Level in the Stimulated Saliva of Caries-Free and Caries-Active Children Aged 7-10 Years
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Background: Salivary immunoglobulin IgA plays an essential role in the immune response against dental caries. This studywas conducted to compare the salivary IgA levels and flow rate of stimulated saliva in caries active and caries free children. Materials and methods: The present study included sixty healthy children age 7-10 yearswho were divided into two groups. They were caries free and caries active children (30 children in each group). Assessment and recording of caries – experience were through the application of Decayed, Missing and Filled Tooth Index (DMFT) and (dmft) index, for permanent and deciduous teeth respectively. After dental examination, stimulated saliva samples were collected from the subjects and performed und

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