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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 31 2023
Journal Name
Journal Of Pioneering Medical Science
Determination of Coronary Care Unit Nurses' Knowledge Regarding Patient Rehabilitation After Myocardial Infarction
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Background: Cardiovascular disease (CVD) is the number one cause of death worldwide. Objective: To determine of coronary care unit nurses' knowledge regarding patient rehabilitation after myocardial infarction. Methodology: A cross- sectional study was designed in the Cardiac Care Unit of Al-Diwaniyah Teaching Hospital and the Specialized Center for Cardiac Surgery and Catheterization for the period from (November 7, 2022) to (May 12, 2023). A non-probability (purposive) sample consisting of (75 nurses) working in the above-mentioned study site. To determination of coronary care unit Nurses' knowledge regarding patient rehabilitation after myocardial infarction, the researcher used a tool that consists of two parts: The first part:

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Publication Date
Sun Jun 01 2014
Journal Name
International Journal Of Biological & Pharmaceutical Research
PROMASTIGOTES VIABILITY OF LEISHMANIA MAJOR W.T. ANDL. MAJOR KNOCKOUT LMLCB2 AFTER MYRIOCIN TREATMENT
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Sphingolipids (SLs) are major structural constituents of eukaryotes, including the kinetoplastid parasite Leishmania. SLs are important for cellular trafficking and signaling and participate in different cell functions, such as, differentiation and cell death (apoptosis). In this study we have investigated the viability of Leishmania major wild type (W.T) and L. major knockout LmLCB2, one of two subunits of serine palmitoyl transferase (SPT) after treatment with myriocin (potent inhibitor of SPT) in order to detect the survival and proliferation of the parasites in vitro. This is to focus on the de novo sphingolipids biosynthesis pathway in both Leishmania wild type which can synthesize SPT and knockout Leishmania which genetically ablated

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Publication Date
Mon Jun 30 2014
Journal Name
Al-kindy College Medical Journal
Is Elective Interval Appendicectomy after Successful Initial Conservative Management of Appendicular Mass Necessary?
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Background The traditional management of appendicular mass is an initial conservative treatment followed by interval appendectomy. Recently interval appendicectomy has been questioned.
Objective: The purpose of this study was to clarify the need and the role of interval appendicectomy after successful initial conservative treatment.
Method: This is a prospective study conducted in a major hospital in Basra from April 2006 to Septemper2010, included 65 patients with appendicular mass which subsequently proved postinflammmatory (phlegmonous) changes of the appendix were treated conservatively.
Results: Routine interval appendicectomy was not performed and needed after successful treatment in the majority of the patients (84.6%). F

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Publication Date
Tue Aug 26 2025
Journal Name
Journal Of Contemporary Medical Sciences
Psychosexual Consequences that Iraqi Women Suffer after Emergency Hysterectomy
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Publication Date
Tue Aug 26 2025
Journal Name
Journal Of Contemporary Medical Sciences
Psychosexual Consequences that Iraqi Women Suffer after Emergency Hysterectomy
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Publication Date
Wed Sep 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Shear Bond Strength of Three Different Brackets Bonded on Zirconium Surfaces (In Vitro Study)
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Background: With the increased in the demands of adult orthodontics, the challenge of direct bonding to non-enamel surface (zirconium) had been increased. The present study was carried out to compare the shear bond strength of three different brackets (stainless steel, sapphire and composite) bonded to zirconium surface and study the mode of bond failure. Materials and methods: The sample was comprised of 30 models (8mm *6mm*1.5mm) of full contour zirconium veneers. They were divided into three groups according to the brackets type; all samples were treated first by sandblast with aluminum oxide particle 50 µm then coated by z-prime plus primer. A central incisor bracket of each group was bonded to the prepared zirconium surface with lig

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Publication Date
Sun Feb 24 2019
Journal Name
Iraqi Journal Of Physics
Comparison of three interpolation methods for the average monthly temperature in the south of Iraqi zone
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This study focuses on evaluating the suitability of three interpolation methods in terms of their accuracy at climate data for some provinces of south of Iraq. Two data sets of maximum and minimum temperature in February 2008 from nine meteorological stations located in the south of Iraq using three interpolation methods. ArcGIS is used to produce the spatially distributed temperature data by using IDW, ordinary kriging, and spline. Four statistical methods are applied to analyze the results obtained from three interpolation methods. These methods are RMSE, RMSE as a percentage of the mean, Model efficiency (E) and Bias, which showed that the ordinary krigingis the best for this data from other methods by the results that have b

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Publication Date
Tue Aug 23 2022
Journal Name
International Journal Of Health Sciences
Role of activin a hormone, betacellulin (BTC) growth factor, and Heparin binding epidermal growth factor on mice embryonic development after oral administration of glycyrrhiza glabra
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Glycyrrhiza glabra is a herbal plant used for treatment of many infertility diseases. Its roots, a common herbal source, are described to soothe fetuses in pregnant mice, but there isn't enough research to know if it's safe to take during pregnancy and its effects on implantation factors. This study examines the impact of the growth factors betacellulin (BTC), heparin-binding epidermal growth factor, and activin A hormone on embryonic development after oral administration of Glycyrrhiza glabra aqueous extract to mice. In line with clinical use, an aqueous extract of Glycyrrhiza glabra roots was prepared. Pregnant mice were randomly assigned to one of four groups: Two mice groups 8 and 28 weeks old treated with water as a negative co

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Publication Date
Sat May 23 2026
Journal Name
Sciences Journal Of Physical Education
Cognitive bias and its relationship to the performance of the two skills of standing on (hands and the human wheel) on the floor movement carpet device in the artistic gymnastics for women
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Publication Date
Sun Jan 01 2017
Journal Name
South Asian Journal Of Life Sciences
Comparison the Effect of Fungi (Beauveria bassiana) and Bacteria Bacillus thuringiensis (israelensis) on a Cumulative Mortality of Culex Quinquefasciatus (Diptera: Culicidae)
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