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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 30 2013
Journal Name
Al-kindy College Medical Journal
Serodiffusion of Helicobacter Pylori and HAV in Patients Attending Two Centers in Baghdad
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Background: Helicobacters are motile curved, oxidase and catalase positive,
gram negative rods similar in morphology to vibrios. The cells have polar flagella
and are often attached at their ends given pairs "S" shapes or seagull
appearance.
Object i ves: The present study was undertaken to estimate the serodiffusion of
H. pylori and hepatitis A virus (HAV) in 300 patients attending two centers in
Baghdad.
Metthods:: HAV was determined by the detection of HAV-IgM in the serum samples. Detection of H. pylori was by ELISA and endoscopic examination.
Resul t s: The serodiffusion of H. pylori was 40% (n=120). Out of the 120
patients infected with H. pylori, 50(41 .6%) patients were diagnosed clinically to
have g

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Publication Date
Wed Sep 15 2010
Journal Name
Journal Of Baghdad College Of Dentistry
Computerized measurement of bite forces for edentulous subjects with denture bases of different impression techniques
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Background: Complete denture wearers show lower levels of bite force than dentate subjects. This has a significant influence on their chewing efficiency. In this study an attempt was made to investigate the effect of the impression technique on the maximum bite force in complete denture wearers. Materials and methods: The patients selected for this research were 12 edentulous patients. Three different techniques for registering the final impression were made; the mucostatic, mucofunctional, and the selective pressure impression technique. Two sets of upper and lower denture bases and one set of upper and lower dentures were constructed for each subject. Intraoral and extraoral instruments and devices, as well as a computer program were used

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Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparing parameters and Reliability of two-parameters exponential
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One of the most important problems in the statistical inference is estimating parameters and Reliability parameter and also interval estimation , and testing hypothesis . estimating two parameters of exponential distribution and also reliability parameter in a stress-strength model.

This parameter deals with estimating the scale parameter and the Location parameter µ , of two exponential distribution   ,using moments estimator and maximum likelihood estimator , also we estimate the parameter R=pr(x>y), where x,y are two- parameter independent exponential random variables .

Statistical properties of this distribution and its properti

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Publication Date
Wed May 12 2021
Journal Name
Indian Journal Of Forensic Medicine & Toxicology
The Relationship of Healthy Rationalist Pundit Thinking to the Spiking and Block Performance of Volleyball For Junior Players
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Publication Date
Tue Nov 01 2016
Journal Name
Journal Of Cosmetics, Dermatological Sciences And Applications
Frequency of benign and malignant tumors in localized vitiligo in comparison to generalized and universal vitiligo
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KE Sharquie, AA Noaimi, SJ Murtada…, Journal of Cosmetics, Dermatological Sciences and Applications, 2016 - Cited by 4

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Publication Date
Wed Apr 30 2025
Journal Name
مجلة دراسات دولية
China-Russia relations after 2013: motives and determinants
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This research aims to identify the reality of Sino-Russian relations after 2013, and to study the most important motives and determinants that affected the nature of these relations. The research was based on the criterion of national interest in interpreting and understanding relations between China and Russia, on the basis that national interest is what determines the state of cooperation and dependence, or the state of competition and difference. The research was based on the hypothesis that Sino-Russian relations after 2013 witnessed many factors and variables, some of which represented motives for strengthening relations between the two countries, and others represented obstacles that limit the level of cooperation and interaction betw

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Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
power and chinese Abilities development after cold war
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Abstract: This research deals with the developing of power and different abilities (military, security, economy, technology and scientific excellence) The research shows that the excellence of the Chinese economy and its development , had a positive reflection on the other powers and abilities , it means it is a base of development in all fields. The development in power and Chinese military abilities had a clear effect on Chinese strategic creed , and that what the research deals with in some details. The research also deals with developing Chinese nuclear abilities. The research doesn't ignore the security eye that indicates to the protection of the state sovereignty, concentrating on the unity and safety Chinese lands. The res

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Publication Date
Fri Oct 28 2022
Journal Name
Political Sciences Journal
The Path of China-India Relations After 2013: Opportunities and Challenges
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China and India are considered both rising countries, and both are among the world's most populous and fastest growing economies. The long-term growth of both China and India has reinforced the importance of their bilateral relationship. The relations between China and India are complex, as relations between them have undergone great changes during the past seven decades, ranging from friendship to hostility. This study proceeds from the hypothesis that the nature and path of Sino-Indian relations after 2013 are affected by several factors and variables, some of which represent opportunities, others represent challenges and obstacles. Several opportunities have contributed to the reformulation of bilateral relations in terms of mutual ga

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Publication Date
Mon Nov 03 2025
Journal Name
Frontiers In Dental Medicine
Effects of cavity depth (moderate vs. deep with pulp exposure) on the release of prostaglandin E2 and nitric oxide in rat mandibular incisors
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Background/objectives: Inflammatory mediators such as prostaglandin E2 (PGE2) and nitric oxide (NO) are key indicators of pulp response to mechanical trauma. However, the influence of cavity depth on their release dynamics remains unclear. This study aimed to evaluate the effects of different cavity depths—moderate (without pulp exposure) and deep (with pulp exposure)—on the release of PGE2 and NO in the pulp tissue of rat mandibular incisors at two time intervals (3 and 9 h).Methods: In total, 40 male Wistar rats were divided into two main groups (n = 20) based on cavity depth. A split-mouth design was used, with cavities of different depths prepared on the left mandibular incisors, leaving the right incisors without cavities as

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Publication Date
Sun Dec 31 2000
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Preparation of Zeolite 4A and Studying the Operating Conditions of the Agglomeration in the Inclined Rotary Disk
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