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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 01 2014
Journal Name
Baghdad Science Journal
Effect of the fungus Metarhizumanisopliae (Metchnikoff) Sorokin and actelic insecticide in the protection of bean seeds packaged in bag from infection by cowpea beetle
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this study was perform to defined the effect of fungus Metarhiziumanisopliae Sorokin with concentrations 5x101, 5x103 and 5x105 spore/ ml and Actelic insecticide with concentration 0.001% in in rate of germinate treated string bean seeds also study effect of packed bags in two different type: jute and polypropylene bags which treated with fungal suspension pervious mention and insecticide in rate infested the string bean seeds packed in it.Results of the study showed the following: Lower rate of weight loss of cowpea seeds appear in poly propylene bags 4.41, 5.95% after six months of treatment with 5x 105 spore/ ml and Actelic insecticide respectively compared with 15.08% to control treatment. The fungal concentrations and insecticide not

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Publication Date
Wed Oct 11 2023
Journal Name
Journal Of Educational And Psychological Researches
The Effectiveness of Cognitive-Behavioral Counseling in Reducing Symptoms of Social Anxiety and Improving Social Skills among Intermediate School Students in Dhi Qar Governorate
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The study aims to investigate the effectiveness of cognitive-behavioral counseling in reducing symptoms of social anxiety and improving social skills among a sample of intermediate school students in the city of Souq Al-Shuyukh at Dhi Qar Governorate. The sample consisted of (40) female students, their ages ranged (14-15). They were selected based on their high scores on the social anxiety scale. The sample was divided into two groups: an experimental group, and a control group, equal in number (20) students in each group. The researcher used the social anxiety scale and the social skills scale. In addition, he used the cognitive-behavioral counseling program, consisting of (11) counseling sessions, with a rate of (45) minutes per sessio

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Publication Date
Sat Dec 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
The Physical Evidence Of The Product And Its Impact In Attracting The Customer AField research for a sample of private medical clinics in Maysan
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Abstract

     The current research problem includes a variety of research motivations to serve the private health sector, which is witnessing a great competition from internal and external environments. In this regard, private medical clinics are increasingly seeking to attract and retain customers through the quality of their service offerings represented by health services. Innovative and effective marketing methods to improve performance and stay in competition, by relying on the physical evidence of the product as a component of the marketing mix of services and its role in particular in packaging and supporting the health service with concrete evidence that affects the customer an

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Publication Date
Thu Jun 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
The Trends of Fiscal Policy in bearing the financial burden of the government and the Extent Leadership in Iraq during the period 2004- 2014
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Abstract

There has been a heated controversy over the role the financial policy plays and how sufficient   it   is   in affording   the   financial   burden. This   burden   is   known as the operational   current expenses   which   the   governments   of   various countries mainly afford,   despite the   discrepancy   in   the   government’s   economic   policy.   After   the deterioration and deficit in the state budget in all countries nowadays, it was necessary to find an appropri

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Publication Date
Wed Feb 25 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of the anterior loop of the mental nerve incidence and extension in different age groups in Sulaimania city using digital panoramic imaging system
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Background: The anterior loop of mental nerve is commonly described as that part of the neurovascular bundle that transverses anterior and inferior to the mental foramen only to loop back to exit the mental foramen. The aim of the study is to evaluate the incidence and extension of anterior loop of mental nerve by using digital panoramic imaging system to avoid nerve damage during different surgical procedures in dentistry. Materials and Method: Panoramic image was taken for all 400 patients and stored in the computer. Then Horizontal and Vertical for the anterior loop extension when exist was measured and recorded in a special case sheet prepared for each subject. Results: Results indicated that out of 400 patients there were only 25 pat

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Publication Date
Tue Jul 11 2023
Journal Name
Journal Of Educational And Psychological Researches
The Level of Psychological Burnout among University Professors in Light of Armed Conflicts in Yemen: Center for Political and Strategic Studies - Sana'a University - Yemen
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The research aims to identify the level of psychological burnout among the professors of Sana’a University in light of the armed conflicts in Yemen. The research sample consisted of (104) faculty members. A descriptive-analytical approach was adopted. The results of the research showed that university professors suffer from psychological burnout at a very high level in the overall score of the scale. There were no statistically significant differences in terms of gender, academic degree, teaching experience, marital status, number of family members, or salary. In light of the results, the researcher presented a number of relevant recommendations and suggestions.

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Publication Date
Tue Jan 09 2024
Journal Name
Wasit Journal Of Sports Sciences
A Comparative Analytical Study of Some Biomechanical Variables and Their Relationship to The Accuracy of The Performance of The Shooting Skill of Jumping High in The Weak and Strong Foot the Players for Youth Handball
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The research aims to identify the most important variables affecting shooting from jumping high and compare them for the two foot the weak and strong, where the researchers adopted the descriptive method, and the sample was chosen by the intentional method, which consists of (4) players from the Iraqi Sports Army Club, where these variables were studied and their impact on The accuracy of aiming at the two men, and the researchers concluded that most of the players have more accuracy in aiming at the strong leg than at the weak leg, which leads to the loss of many real opportunities during the match because of the players changing the situation or wasting the available opportunity when the position of correction is an opportunity for the w

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Publication Date
Mon Dec 20 2021
Journal Name
لارك
The Theme of the Family in Russian Literature during the "Thaw" on the Material the story of M. Sholokhov "The Fate of a Man"and the story of V. Panova "Seryozha" and F. Abramov "Fatherless".
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The article approaches the characteristics of Russian literature in the time of Khrushchev or the "thaw" period a very short period of Soviet history, characterized by the easing of the dictatorship of power and relaxation in various areas of people's lives. The interest in the research is focused on the importance of interpreting the family portrait in a short but distinct period in the development of Russian/Soviet literature. The research material is the story of Sholokhov's “The Fate of Man” 1956, the story of Panova “Serioga” 1955, and Abramov’s story “Fatherless” 1961. В статье рассматриваются особенности художественной литературы периода хруще

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Publication Date
Mon Apr 01 2024
Journal Name
Indian Journal Of Dental Research
Effect of Bisoctrizole on Ultraviolet (UV) Absorption Properties of Silicone and Effect on Surface Roughness - An In Vitro Study
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Abstract<sec> <title>Background:

Premature degradation is the problem of maxillofacial silicones, significantly affected by ultraviolet exposure, contributing to silicones photodegradation. Degradation necessitates frequent replacement of prostheses that increase the total cost of rehabilitation.

Aims:

This study evaluated the effect of bisoctrizole on the ultraviolet absorption properties of silicone material and the stability of this absorption over time. Also, the bisoctrizole effect on the surface roughness of silicone was evaluated.

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Publication Date
Wed Dec 01 2021
Journal Name
International Medical Journal
Knowledge and Attitude of Iraqi Dentists towards the Use of Cone Beam Computed Tomography in Endodontics: A Questionnaire Study
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Objective: The aim of this study was to assess the knowledge and attitude of Iraqi dentists towards cone beam computed tomography (CBCT) applications in endodontics by using an online survey. Materials and Methods: A questionnaire, consisting of 31 questions, targeted general dental practitioners and specialists in different dental specialities. A total of 306 participants were included. Data were assessed according to the frequency of distribution and the chi-square test was applied to analyse the difference in responses between two independent groups. Results: Among the participants 63.4% were using digital radiography in their daily practice, and 84% had awareness about CBCT's uses, with higher statistically significant responses among e

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