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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Dec 25 2025
Journal Name
Sultan Qaboos University Medical Journal
Clinical and Molecular Analysis of ATP7B Variants Identified by Next-Generation Sequencing in Iraqi Adults With Wilson Disease
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Objectives: This study aimed to identify and analyse ATP7B variants in Iraqi adults with Wilson disease (WD) by long-read next-generation sequencing. Methods: This cross-sectional study was conducted at the Poisoning Consultation Center at Ghazy Al-Hariri Hospital for Surgical Specialties and the Gastroenterology Consultation Clinic at Baghdad Teaching Hospital, Medical City in Baghdad, Iraq. Unrelated patients with clinical and biochemical features suggestive of WD were recruited between October 2022 and October 2023. DNA was extracted from peripheral blood samples. Variants in the ATP7B gene were identified using long-read next-generation sequencing and then analysed by in-silico tools. Results: A total of 45 patients were recruited in

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Scopus
Publication Date
Tue Apr 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
Evaluation Age and Gender for General Census of the population in Iraq by using nonparametric Bayesian Kernel Estimators
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The process of evaluating data (age and the gender structure) is one of the important factors that help any country to draw plans and programs for the future. Discussed the errors in population data for the census of Iraqi population of 1997. targeted correct and revised to serve the purposes of planning. which will be smoothing the population databy using nonparametric regression estimator (Nadaraya-Watson estimator) This estimator depends on bandwidth (h) which can be calculate it by two ways of using Bayesian method, the first when observations distribution is Lognormal Kernel and the second is when observations distribution is Normal Kernel

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Publication Date
Mon Dec 18 2017
Journal Name
Al-khwarizmi Engineering Journal
Experimental Study of Mixed Convection in an Enclosure with a Cold Movable Top Wall and Hot Bottom Wall
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Mixed convection heat transfer to air inside an enclosure is investigated experimentally. The bottom wall of the enclosure is maintained at higher temperature than that of the top wall which keeps in oscillation motion, whereas the left and right walls are well insulated. The differential temperature of the bottom and top walls changed several times in order to accurately characterize the temperature distribution over a considerable range of Richardson number. Adjustable aspect ratio box was built as a test rig to determine the effects of Richardson number and aspect ratio on the flow behavior of the air inside the enclosure. The flow fields and the average Nusselt number profiles were presented in this wo

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Publication Date
Wed Jul 01 2015
Journal Name
Advanced Powder Technology
Characterization of nano-silica prepared from local silica sand and its application in cement mortar using optimization technique
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Publication Date
Fri Dec 19 2025
Journal Name
Nursing Science Quarterly
Investigating the Ethical Challenges and Quality of Care for Patients on Psychiatric Units With Aggressive Behaviors in Iraq
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Patient aggression is a global health care problem. This study examined the impact of patient aggression on the quality of care that patients receive as perceived by their family members and the ethical challenges involved from the nurse’s perspective. A descriptive–analytical method was used. The participants of this study were nurses working on psychiatric units and family members of patients in Iraq. Two questionnaires were used: one on nursing care quality and one on ethical challenges in clinical situations. The results showed that the quality of care for these patients was reduced, with a M ±

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Publication Date
Sat Feb 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
Analaysis of the lmpacyt fiscal policy in Iraq on stabilization and economic growth for the period (2003-2010)
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        The vision and philosophy of the economic system in Iraq after 2003 were not clear-cut because of overlapping internal factors was the novelty of the political system and the lack of political and economic decision makers to understanding and conviction full need shaping a new administration for the Iraqi economy is able to succeed economic development programs, and external factors was determinedly organizations international application of shock reforming style and contrary to the social reality and the security which reflected negatively on the work and consistency Lisseeash financial balance between stability and growth and raise the level of consumer spending and the importance of r

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Publication Date
Fri Mar 01 2024
Journal Name
International Communications In Heat And Mass Transfer
Accelerated charging of PCM in coil heat exchangers via central return tube and inlet positioning: A 3D analysis
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Publication Date
Mon Apr 01 2019
Journal Name
Journal Of Educational And Psychological Researches
Violence Efficacy of Parents in Consolidating the Positive Values and Its Relation with Socialization among Intermediated School Students
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The research aims to identify the effectiveness of violence by parents in the consolidation of positive values among students. Additionally, the research aims to identify the differences in violence levels among students regarding their gender (males & females). The study was limited to the intermediate school students in Baghdad city / Karkh2 for the academic year 2017-2018. The results showed that males are more violent than females do and that discrimination led to experience violence more than other methods. The researcher recommends the need to create a positive atmosphere within the school context. For future studies, the researcher suggests conducting a study to identify the violence and its relation to some personal character

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Publication Date
Mon May 04 2020
Journal Name
Environmental Engineering Research
Experimental and modeling study of water defluoridation using waste granular brick in a continuous up-flow fixed bed
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Contamination of surface and groundwater with excessive concentrations of fluoride is of significant health hazard. Adsorption of fluoride onto waste materials of no economic value could be a potential approach for the treatment of fluoride-bearing water. This experimental and modeling study was devoted to investigate for the first the fluoride removal using unmodified waste granular brick (WGB) in a fixed bed running in continuous mode. Characterization of WGB was carried out by FT-IR, SEM, and EDX analysis. The batch mode experiments showed that they were affected by several parameters including contact time, initial pH, and sorbent dosage. The best values of these parameters that provided maximum removal percent (82%) with the in

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Publication Date
Sat Jan 01 2022
Journal Name
Communications In Mathematical Biology And Neuroscience
The impact of fear and harvesting on plankton-fish system dynamics incorporating harmful phytoplankton in the contaminated environment
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