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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Jan 01 2023
Journal Name
3rd International Conference On Smart Cities And Sustainable Planning
Power between potentiality and actuality in urban sustainability and urban resilience
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Publication Date
Fri Jan 01 2010
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Thesis
Design and Implementation proposed Encoding and Hiding Text in an Image
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NAA Mustafa, University of Sulaimani, Ms. c Thesis, 2010 - Cited by 4

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Publication Date
Sun Dec 10 2017
Journal Name
Al-academy
Tradition and modernity in the designs and fabrics fashion gowns Islamic
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The importance of the heritage of the Iraqi heavy symbolism and connotations where contacted habits rights and beliefs from antiquity to the present, in addition to being represented with data aesthetic it is an expression philosophical concepts associated implications incentives cultural aesthetic of the content of the intellectual including contents of semantics and symbols and the dimensions of the meanings Sayings , to turn form a legacy popularly moving window to communicate worth studying its details and search function on the character and identity and origins . Where have emerged in recent years, a phenomenon characterized by inventing new designs by modernist styles that have entered into technical system design and effectivenes

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Publication Date
Thu Dec 15 2022
Journal Name
Al-academy
Decorative supplements and their role in fabric designs and women's fashion
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The decorative supplements added are important factors in determining many decorative effects and how to implement them, whether in fabrics or fashion, and also work to determine the nature of perception for both the designer and the recipient and have a key role in shaping the human personality and determining his motives and emotional tendencies in the acquisition of fabrics and fashion and the vocabulary they carry A design that has certain connotations and symbols that gain its value from the effects it leaves on the physical formations of women. The problem of the research came with the following question (What are the decorative supplements and their role in the designs of fabrics and women’s fashion?) The research also dealt wit

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Publication Date
Fri Sep 20 2019
Journal Name
Journal Of The College Of Education For Women
Community Innovation and Its Role in Gender Mainstreaming and Development Issues
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Gender mainstreaming is a goal for building a society characterized by justice and equality. Gender mainstreaming requires a clear understanding of the concept. Therefore, the research focuses on the concept of gender and how it was addressed in the literature through which the concepts related to gender were extracted which is represented by the role and social status through which the relationship of gender can be measured. In order to find out the basis for the different status and roles of both sexes in societies, the interpreted theories of gender were addressed, through which the most important factors affecting gender relations, such as biological, social and economic factors, as well as political systems, were discussed. Due to t

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Publication Date
Mon Feb 15 2021
Journal Name
Arab World English Journal For Translation And Literary Studies
Insanity and Murder in Robert Browning’ and Robert Lowell’s Dramatic Monologues
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The study aims at fathoming Robert Browning’ and Robert Lowell’s intentions of choosing the dramatic monologue as a means of exploring human psyche. Significantly, the themes of insanity and murder are not ideal from an esthetic perspective, but for Browning and Lowell it provides the key to probe into human character and fundamental motives. This study examines Browning’ and Lowell’s dramatic monologues that address crime and the psyche of abnormal men. Browning’ and Lowell’s poetry in this regard unravels complicated human motivations and delineates morbid psychologies. Their monologues probe deep down into the mind-sets of their characters and dissect their souls to the readers. The main character of each of Browning

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Publication Date
Thu Oct 01 2015
Journal Name
Al-academy
Problems between acter and director in film and t.v: صالح الصحن
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Constitute the relationship between the director and actor mainstay chock done to show art in film and television , both of which occupy what a big role in the mission accomplishment . The leadership of the director of the artwork in various joints require two features two important ( creativity and administration ) , The capabilities director of creative serves as an added intellectual and aesthetic saturated sensation that leaves its impact on all the technical elements involved in done. Either trait administration and leadership it is what requires multiple skills in dealing on according to technical standards and moral and humanitarian allow the transfer of ideas , concepts and visions to those elements to embody and implement the ki

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Publication Date
Sun Dec 01 2019
Journal Name
Journal Of Coloproctology
Rectal cancer and chemoradiation in Iraq: systematic review and meta-analysis
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Abstract<p> Background Rectal cancer is one of the most common malignant tumors of gastrointestinal tract. Combining chemotherapy with radiotherapy has a sound effect on its management.</p><p> Objectives Assessment the patterns of characterizations of rectal cancer. Evaluation of the efficacy, and long-term survival of pre-/ postoperative chemoradiation. Collecting all eligible evidence articles and summarize the results.</p><p> Methods By this systematic review and meta-analysis study, we include data of chemoradiation of rectal cancer articles from 2015 until 2019. The research was carried out at Baghdad Medical City oncology centers. Accordance with the</p> ... Show More
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Publication Date
Tue Nov 03 2020
Journal Name
Modern Sport
The requirements of sustainable development for colleges of physical education and sports science in Iraq
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l development in addition to environmental reform, which is not possible at its best, and from this the faculties of physical education and sports science realize the scale of the problem and its importance in the development of society that this all puts on the faculties of education Physical and sports sciences are a very difficult task and an end in holiness, for it is the responsibility of the human development service and its leadership, because the community leaders and its elites are those who value their direction and future more than others. The importance of this study comes from the goal of sustainable development to maximizing pain. The net gain from higher education while ensuring the preservation of the quality of reso

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Publication Date
Tue Jun 25 2024
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Effect of PM2. 5 and PM10 on the Hematopoietic System of Cafés Workers in Baghdad
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The aim of our current study was to identify the effect of particulate matter of both types (PM2.5 and PM10) resulting from hookah smoking on the hemopoietic system of workers (smokers) in closed cafes. This study included six stations (cafes) on the Rusafa side of Baghdad city and conducted a blood test that included a complete blood count (CBC). A multifunctional air quality detector measured both types of particulate matter in the morning and evening. The study included 30 men (workers and smokers) and 30 men (non-smokers), whose ages ranged from 20 to 40 years. The study found that smokers had an increase in white blood cells and red blood cells, as well as an increase in the percentage of hemoglobin (HGB), hematocrit (HCT), the mean co

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