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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 14 2016
Journal Name
Al-academy
Employing traditional symbols and popular beliefs in the designs of fabrics, clothing women's home
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The woman's choice of clothing is no longer supported on the basis of the available forms of design in general. It is the interaction of design relationships with the receiver structure that reflects the character of integrated women with an emphasis on attractions pulling attention, all of these interventions reach us to the need to emphasize through this search Picking the perfect symbols of heritage in every sense of the popular beliefs of the employed in the designs of apparel fabrics women's home included a search of four chapters deal with the first problem of the research which you can employ the traditional symbols and popular beliefs in the designs of household apparel fabrics in order to raise the aesthetic value and utility of

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Publication Date
Thu May 05 2022
Journal Name
Al-kindy College Medical Journal
Has exogenous melatonin induce histological changes in collecting tubules and ducts of rat's kidney?
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Back ground; Selective re-absorption and secretion are the functions of the collecting tubules and ducts, in addition to concentrate urine through ADH-regulated and ADH-independent water channels.Method; twenty four male rats were used, they were divided into two groups of animals: Group (A) included twelve rats of five weeks old age (before puberty) that were divided into three subgroups, four rats in each subgroup. Subgroup I was control one, subgroups II and III were treated orally with melatonin in a dose of 250 & 500 µg/kg body weights subsequently. Group (B) included twelve rats of seventeen weeks old age (after puberty) that were divided into the same subgroups and treated with the doses of melatonin as in the rats of group (

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Publication Date
Mon Jun 20 2022
Journal Name
Journal Of Positive School Psychology
The Role Of Product Lifecycle Cost Technology And Cleaner Production Strategy In Reducing Costs
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Reducing costs and protecting the environment surrounding economic unity has become the concern of many economic units and shifting their ideas towards preserving resources and protecting the environment by adopting strategies and techniques that take into account when applied reducing production costs and protecting the environment, including these strategies and techniques, the technical costs of the product life cycle and the strategy of cleaner production, as the application of the two concepts in local economic units helps to try to keep up with the countries that work to keep up with the success of their economic units by following the concepts that have been successful in  Developed countries by maintaining the sustainabilit

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Publication Date
Sat Aug 03 2013
Journal Name
European Journal Of Scientific Research
Serum Levels of Anti Intrinsic Factor Antibodies and α1- Antitrypsin in Alcohol-Dependent Males
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Excess alcohol consumption is associated with numerous metabolic changes and homeostasis disturbances of many macro- and micro-elements in the body. It has been associated with multiple pathologies at all levels. In the digestive apparatus, alcohol has generally been related to its toxic effects upon the liver. Alpha-1 antitrypsin (α-1 AT or AAT) plays an important role in controlling inflammation, coagulation and repair mechanisms in the body and most α-1 AT in the body is produced by the liver; from the other hand, Intrinsic factor (IF), which is a glycoprotein produced by the parietal cells of the stomach is necessary for the absorption of vitamin B12 in the small intestine. This study was designed to assess serum levels of α-1 AT and

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Publication Date
Tue Aug 15 2023
Journal Name
Al-academy
Parametric design tools and how to take advantage of it in 3D sculptural design
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The design was distinguished in Late Twenty-First Century With new and new methods Through which the ability to adapt all technical media in the formation of two-dimensional and three-dimensional figures and shapes was achieved .
Which led to the emergence of endless sets of design ideas characterized by the heterogeneity of design forms and design solutions that preceded it. The designer could not access these creations in various architectural and artistic fields only through computer programs, especially those related to the activation of mathematical logic and what is known as algorithms in the formation and construction of the form, which led to the emergence of the "parametric direction" and the problem of research is summarized

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Publication Date
Wed Jan 01 2020
Journal Name
Plant Archives
The effect of temperature on cadmium adsorption and desorption in some iraqi calcareous soils
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Publication Date
Mon Jun 01 2020
Journal Name
Life Sciences
Synthesis, characterization and anticancer activity in vitro evaluation of novel dicyanoaurate (I)-based complexes
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Publication Date
Sat Jan 01 2022
Journal Name
Journal Of Pharmaceutical Negative Results
Total Oxidants, Lipid Peroxidation and Antioxidant Capacity in the Serum of Rheumatoid Arthritis Patients
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Publication Date
Mon Mar 04 2024
Journal Name
Journal Of Emergency Medicine, Trauma And Acute Care
A comparative immunohistochemical expression of cytokeratin 19 in odontogenic keratocyst, dentigerous, and radicular cysts
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Background: Odontogenic cysts are characterized by their sluggish growth and ability to enlarge, primarily affecting the oral and maxillofacial tissues. Timely diagnosis and treatment are crucial to prevent potentially serious consequences. The present study aimed to evaluate and compare the immunohistochemical expression of cytokeratin 19 in the epithelium of odontogenic keratocyst, dentigerous, and radicular cysts.

Methods: This study analyzed forty-five formalin-fixed, paraffin-embedded tissue blocks containing odontogenic cysts. The sample consisted of fifteen odontogenic keratocysts, fifteen dentigerous cysts, and

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Publication Date
Fri Mar 29 2024
Journal Name
Iraqi Journal Of Science
Involvement of Total Antioxidant Activity and eNOS Gene rs1799983/ rs2070744 Polymorphisms in Breast Carcinogenesis
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Globally, breast cancer is the common malignancy affecting women and understanding its associated molecular events could help in disease prevention and management strategies. The present study was set to investigate an association between total antioxidant capacity (TAC) and endothelial nitric oxide synthase (eNOS) polymorphisms with breast cancer. For this purpose, 100 subjects were participated in this work, including 50 female patients diagnosed with breast cancer recruited from Oncology hospital, Baghdad - Iraq and 50 healthy women as a control group. The concentration of antioxidants was measured in the serums collected from blood samples of breast cancer patients and healthy controls. While eNOS SNPs (rs1799983, G894T and rs2070744, T

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