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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 27 2022
Journal Name
Chemical Papers
Synthesis, characterization, and application of external gelation of sodium alginate nanoparticles in molecular imprinting for separation and drug delivery of tenoxicam
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Publication Date
Fri Jun 20 1930
Journal Name
College Of Islamic Sciences
Evidence of the prophecy of Muhammad peace be upon him and established understanding In the letters of light: Study and analysis
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Provisions and controls on the disposal of public funds between Sharia and law
Research Summary
That money is the foundation of life and one of the most important reasons for the reconstruction of the land, and God is the owner
The real value of this money, God has borrowed some individuals on public money, and people
They are charged with preserving it, since it is beneficial to them all, without anyone taking it
To himself, and the guardian is charged by God to protect this money and aggression
Because of its power, authority, various organs and public servants of the province
Upon him; Because the assault on public money by employees and others in the organs of the state
And exploitation of their jobs and this

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Publication Date
Mon Sep 30 2019
Journal Name
College Of Islamic Sciences
Critical mindset in the philosophy of Sadruddin Shirazi         (D 1050 AH)              And the concepts of originality of existence and what time
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The researcher deals with an important issue in her research - especially as she progresses to the doctoral stage thanks to God (Almighty) and his mentor - the relationship of philosophy to nodal origins. Therefore, she studied the philosophy of Shirazi, which is the key to the mental solutions that the speakers and philosophers stopped. And to conclude scientific results as well as the study of philosophy researcher as a station in the doctoral stage, to be familiar with the philosophical interpretation and the origins of the faith and its philosophical vocabularies such as existence, self, movement, astronomy, time and others. At the same time draw the attention of science students to the issue of philosophical interpretation and its r

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Publication Date
Fri Nov 11 2022
Journal Name
Eurasian Journal Of Physics, Chemistry And Mathematics
Influence of thermophoresis and thermal radiation on mass transfer and heat of Three Dimensional maxwell fluid in presence of Magnetic field
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The study is about Maxwell , three dimensions of non – Newtonian fluid. Method of th Homotopy applied to analysis mass transfer and heat with thermophoresis effects. (Sc), Impact of therrmophoretic (𝜏), magnetic (M), Biot (γ), radiation (Rd),Schmidt Prandtle (Pr) parameters and ratio parameter(β) on concentration, temperature are offered in the paper.

Publication Date
Sun Mar 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Impact of Different Doses of Nicorandil-Induced Ulceration (Oral , Gastrointestinal Tract, and Anal) in Rats: Roles of Leptin and Prostaglandin E2
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Many reports confirm ulcers as an adverse effect of drugs such as nicorandil and aspirin. The exact responsible mechanisms of ulceration have until now not proved. Mucosal ulcers associated with the onset of ulcer are manifested by an increase in proinflammatory cytokine, excessive prostaglandin, and up-regulation of Endothilin-1 level, which directly impacts the release of leptin. These, released locally within mucosal tissues, have played a role in controlling the extent of local inflammatory responses and processes of mucosal repair.
This study was designed to find out the correlation of plasma leptin and prostaglandin levels as a possible mechanism of oral ulcer formation as an adverse effect of nicorandil. The effect of nicorandi

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Publication Date
Sat Jun 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Study and Analysis of the Factors that Affect the Efficiency of Small and Medium Enterprises in the Kingdom of Saudi Arabia
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Encouraging micro-enterprises for comprehensive economic development are crucial to achieve the ambitious vision 2030 of the Kingdom of Saudi Arabia.

 Small and Medium enterprises are inputting around 15.5 per cent to GDP while 33 per cent contribution as a private sector to Saudi Arabia's gross domestic product (GDP). This study aims to identify the most important factors that affect the efficiency of small enterprises in Saudi Arabia. To accomplish this objective, the study was conducted for small projects via the comprehensive inventory method under the supervision of the Institute of Entrepreneurship. A total of 282 questionnaires were collected from entrepreneurs and the differentiation analysis

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Publication Date
Wed Jan 02 2019
Journal Name
Journal Of Educational And Psychological Researches
Women's rights in social studies and national textbooks in the secondary stage in the light of the international charters of women's rights and the cultural specificity of the Saudi society
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Women's rights in social studies and national textbooks in the secondary stage in the light of the international charters of women's rights and the cultural specificity of the Saudi society Abstract The current study focuses on exploring women rights that required to be involved in social studies and national textbooks in the secondary stage in the light of international conventions on women's rights and cultural specificity of the Saudi society, as well as to reveal the teachers and educational supervisors' estimation about the degree of importance of those components included in the books, and then build a matrix of the range and sequence of women's rights in the books of social studies and national in the secondary stage. The study us

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Publication Date
Mon Nov 10 2014
Journal Name
Advances In Language And Literary Studies
The Functions of Onomatopoeia in Modern English and Arabic Poetry: A Study in Selected Poems by Lawrence and al-Sayyab
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Onomatopoeia has always been a functional poetic device which enjoys a high sound significance in the poetry of many languages. In modern English and Arabic poetry alike, it proves to be vital and useful at different levels: musical, thematic and at the level of meaning. Still, the cultural difference looms large over the ways it is employed by the poets of each. The present paper investigates the employment of onomatopoeia in the poetry of D. H. Lawrence (1885-1930) and Badr Shakir al-Sayyab (1926-1964) who are chosen due to the importance they enjoy in modern English and Arabic poetry and the richness of their poems in onomatopoeias. The conclusions reached at are in a sense related to cultural differences which govern the use of onomato

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Publication Date
Tue Apr 20 2021
Journal Name
Ndian Journal Of Forensic Medicine & Toxicology,
Detection Levels of Cytokines (IL-6 and IL-18) and Microbial Parameters in Patients with Renal Failure in Diyala Province
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Publication Date
Mon Jan 01 2024
Journal Name
Clinical Laboratory
Histopathological Tracing of HPV Genotypes 6 and 11 in Pediatric Patients in Medical City with Chronic Palatine and Pharyngeal Tonsillitis
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