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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 27 2022
Journal Name
Journal Of Positive School Psychology .
The Explosive Capacity Of The Muscles Of The Two Men And Their Relationship To The Scoring Of Football Halls
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The research dealt with its forefront a definition of the aspects of the study and its variables, the explosive capacity and its relationship to the scoring of football for the halls and highlights the importance of these variables, and the problem of the research consisted that some players fail to score Amie because of the weak power of shots or the slow scoring, so the researchers saw studying this problem and knowing the extent of the influence of the explosive strength During the performance of the skill of scoring with five football, the study aimed to identify the relationship between the explosive strength and the skill of scoring with five football. Researchers assume that there is a statistically significant relationship between t

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Publication Date
Sun Dec 29 2019
Journal Name
Iraqi Journal Of Science
Calculating the variations of sunrise, sunset and day length times for Baghdad city.With comparison to different regions of the world in year 2019
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     The sunrise, sunset, and day length times for Baghdad (Latitude =33.34º N, Longitude =44.43º E) were calculated with high accuracy on a daily basis during 2019. The results showed that the earliest time of sunrise in Baghdad was at 4h: 53m from 5 Jun. to 20 Jun while the latest was at 7h: 07m from 5 Jan. to 11 Jan. The earliest time of sunset in Baghdad was at16 h: 55m from 30 Nov. to 10 Dec. whereas the latest was at 19h: 16m from 25 Jun. to 5 Jul. The minimum period of day length in Baghdad was 9h: 57m) in 17 Dec. whereas the maximum period was 14h: 22m) in 20 Jun. Day length was calculated and compared among regions of different latitudes(0, 15, 30, 45 and 60 north).

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Publication Date
Tue Aug 25 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Effect of ginger extract on Mutans streptococci in comparison to chlorhexidine gluconate
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Background: The rhizome of ginger is used in cooking and for medicinal purposes such as anti-bacterial, anti-fungal, anti-inflammatory and antioxidant. The aims of the study were to test the effect of ethanolic extract of ginger on growth, adherence and acidogenicity of mutans streptococci in comparison to chlorhexidine gluconate 0.2% and de-ionized water. Materials and methods: From saliva often volunteers (dental students 20-22 years); mutans streptococci was isolated, purified and diagnosed according to morphological characteristic and biochemical tests. Ginger was powdered and extracted, different concentrations of ginger extract were prepared. Chlorhexidine gluconate 0.2% used as a control positive; while de-ionized water was used as a

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Publication Date
Wed Dec 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Semi-parametric Methods in Partial Linear Single-Index Model
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The research dealt with a comparative study between some semi-parametric estimation methods to the Partial linear Single Index Model using simulation. There are two approaches to model estimation two-stage procedure and MADE to estimate this model. Simulations were used to study the finite sample performance of estimating methods based on different Single Index models, error variances, and different sample sizes , and the mean average squared errors were used as a comparison criterion between the methods were used. The results showed a preference for the two-stage procedure depending on all the cases that were used

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Publication Date
Sun Apr 30 2017
Journal Name
Journal Of Engineering
Experimental Study on Heat Transfer and Friction Factor Characteristics of Single Layer Graphene Based DI-water Nanofluid in a Circular Tube under Laminar Flow and Different Heat Fluxes as Boundary Conditions
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An experimental study was performed to estimate the forced convection heat transfer performance and the pressure drop of a single layer graphene (GNPs) based DI-water nanofluid in a circular tube under a laminar flow and a uniform heat flux boundary conditions. The viscosity and thermal conductivity of nanofluid at weight concentrations of (0.1 to 1 wt%) were measured. The effects of the velocity of flow, heat flux and nanoparticle weight concentrations on the  enhancement of the heat transfer are examined. The Nusselt number of the GNPs nanofluid was enhanced as the heat flux and the velocity of flow rate  increased, and the maximum Nusselt number  ratio (Nu nanofluid/ Nu base fluid)   and thermal performance factor

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Publication Date
Sat Jan 01 2022
Journal Name
Revista Iberoamericana De PsicologÍa Del Ejercicio Y El Deporte
THE EFFECT OF TRAINING NETWORK TRAINING IN TWO WAYS, HIGH INTERVAL TRAINING AND REPETITION TO DEVELOP SPEED ENDURANCE ADAPT HEART RATE AND ACHIEVE 5000 METERS YOUTH
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Publication Date
Sun Oct 01 2017
Journal Name
مجلة القادسية للعلوم الرياضية
The impact of leverage in two different environments on the development of weapons and arms explosion strength on some physiological indicators and the accuracy of the performance of the service and crushing volleyball skills
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ھدف البحث الـــــى : ١ -إعداد تدریبات القوة الارتدادیة في وسطین متباینین على بعض المؤشرات الفسیولوجیة لتطویر القوة الانفجاریة ودقة مھارتي الأرسال والضرب الساحق بالكرة الطائرة . ٢ -التعرف على تأثیر تدریبات القوة الارتدادیة في وسطین متباینین على بعض المؤشرات الفسیولوجیة لتطویر القوة الانفجاریة.. ٣ -التعرف على تأثیر تدریبات القوة الارتدادیة في وسطین متباینین على دقة مھارتي الأرسال والضرب الساحق بالكرة الطائرة

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Publication Date
Mon Jan 01 2024
Journal Name
The Scientific World Journal
Mathematical Modeling and Experimental Investigation of the Dynamic Response for an Annular Circular Plate Made of Glass/Polyester Composite Under Different Boundary Conditions
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Fiber‐reinforced elastic laminated composites are extensively used in several domains owing to their high specific stiffness and strength and low specific density. Several studies were performed to ascertain the factors that affect the composite plates’ dynamic properties. This study aims to derive a mathematical model for the dynamic response of the processed composite material in the form of an annular circular shape made of polyester/E‐glass composite. The mathematical model was developed based on modified classical annular circular plate theory under dynamic loading, and all its formulas were solved using MATLAB 2023. The mathematical model was also verified with real experimental work involving the vibration test of the f

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Publication Date
Sat Dec 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Development of Sinusitis After Sinus Floor Elevation Surgery: A Systematic Review
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Background: Maxillary sinusitis can arise after sinus floor elevation surgery and should be treated immediately to prevent further complications which included dental implants failure, graft lost, and oro-antral fistula. This is the first systematic review to assess the incidence, causes, and treatment of sinusitis after sinus lift surgery. Materials and methods: An electronic search included MEDLINE (PUBMED) data base site was carried out for articles involving development of sinusitis after sinus lift surgery from September 1997 up to April, 8, 2017. The search was done and reviewed by two independent authors. Results: The total results of electronic search were (182) abstracts and articles, the extracted articles which involved develo

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Publication Date
Wed Feb 27 2019
Journal Name
Political Sciences Journal
Effects of Neighboring Countries on the Iraqi Parliament Performance after 2003
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