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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Jul 01 2015
Journal Name
Al–bahith Al–a'alami
The Role of the Social Networking Site (Facebook) in the Adjustment of Youth Trends / Community Issues and Problems
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Recent technological developments in the mass media a major paradigm shift in important segments of society, particularly among young people in particular social networking sites including (Facebook) .
it was able to link the sprawling parts of the world and paved the way for all the communities of convergence and exchange views, ideas and desires as provided by their ability to communicate through the use of video clips,pictures,share files, chat, communicate and direct interaction between the audience for this the means. Wondered problem Find the role that can be played using the university youth to the social networking site (Facebook ) to modify their attitudes or their interest in Iraqi society issues, With focused research objec

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Publication Date
Sat Feb 21 2026
Journal Name
Wasit Journal Of Sports Sciences
The impact of the Needham model on learning the skills of dribbling and handling in football for students
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Publication Date
Sat Feb 21 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of antibacterial action of photosensitizer solution activated by diode lamp and three intracanal medicaments (in vitro study)
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Background: The elimination of the microorganisms from the root canal systems, an important step for the successful root canal treatment. This study was conducted to evaluate the antibacterial effectiveness of the photoactivated disinfection by using the toluidine blue O and a low- energy light emitting diode (LED) lamp . Materials and method: Sixty single rooted extracted teeth were decoronated, instrumented, irrigated, sealed at the apex and contaminated with endodontic anaerobic bacteria for 7 days to form biofilms in prepared root canals. Group I. Twelve teeth were medicated by photosensitizer (toluidine blue O) solution activated by diode lamp (FotoSan; CMS Dental, Copenhagen, Denmark).Group II. Twelve teeth were medicated by the tricr

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Publication Date
Sat Mar 08 2025
Journal Name
European Journal Of Agricultural And Rural Education
THE ROLE OF BACTERIA IN REDUCING THE IMPACT OF ENVIRONMENTAL POLLUTION: BETWEEN RISKS AND BENEFITS / A REVIEW ARTICLE
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The objective of this article is to study the impact of environmental pollution on air, water, and soil quality with a focus on the role of environmental bacteria in bioremediation of pollutants. The research also addresses the ability of some strains of bacteria to remove heavy metals and petroleum hydrocarbons and degrade toxic substances, resulting in improved environmental quality. Outcomes: Empirical studies reveal that environmental pollution leads to significant health and environmental problems, such as a rise in respiratory disease as a result of air pollution, water pollution that affects aquatic life, and soil pollution that decreases crop output. Other bacterial strains such as Pseudomonas, Bacillus, and Streptomyces have also b

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Publication Date
Thu Sep 01 2022
Journal Name
Human Gene
Association of CTLA-4 (+49A/G) polymorphism and susceptibility of developing rheumatoid arthritis in an Iraqi Arab population
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Background: The gene responsible for encoding the protein of cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) has been found to be associated with rheumatoid arthritis (RA) in different ethnic populations. But the association of +49A/G CTLA-4 polymorphism with susceptibility of RA among Iraqi Arab populations has not yet been determined. Methods: One hundred and seventy-eight patients were examined, 67 of them were males (mean age 54.71 ± 10.4 years), while 167 were examined for the control group, of whom 64 were males and the rest were females. CTLA-4 DNA genotyping was carried on to determine the +49 A/G (rs231775) polymorphism using a polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Enzyme-linked immuno

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Publication Date
Sun Dec 22 2019
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation of Knowledge, Attitudes and Experience of off-label Drug Prescribing Practice among Physicians in Baghdad City Hospitals
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Abstract

The present study aims to assess the knowledge, attitude, and experience of off-label prescribing practice among physicians in Baghdad city hospitals. This cross-sectional study was performed through the period from November 1st 2018 to March 2019 at 17 hospitals, a self-administered questionnaire was utilized to collect data from the physicians, and the targeted hospitals were randomly selected at different regions in Baghdad City area. Out of the 400 distributed questionnaires to the physicians, 383 of them were returned completed, 57.2% indicated that they were reasonably familiar with the term “off label drug”, 57.7% mentioned that the most common medical reasons for the prescribing o

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Publication Date
Mon Sep 01 2008
Journal Name
Al-khwarizmi Engineering Journal
Design and Simulation of GaussianFSK Transmitter in UHF Band Using Direct Modulation of ΣΔ Modulator Fractional-N Synthesizer
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This research involves design and simulation of GaussianFSK transmitter in UHF band using direct modulation of ΣΔ  fractional-N synthesizer with the following specifications:

Frequency range (869.9– 900.4) MHz, data rate 150kbps, channel spacing (500 kHz), Switching time 1 µs, & phase noise @10 kHz = -85dBc.

New circuit techniques have been sought to allow increased integration of radio transmitters and receivers, along with new radio architectures that take advantage of such techniques. Characteristics such as low power operation, small size, and low cost have become the dominant design criteria by which these systems are judged.

A direct modulation by ΣΔ  fractional-N synthesizer is proposed

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Publication Date
Tue Mar 31 2020
Journal Name
College Of Islamic Sciences
The Origin of Creation in Khattab (The Beginning of Creation) by Imam Ali (as) and Genesis (Comparative Study)
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The research aims to answer the questions that revolve in the mind of mankind about how to create creation, how it existed prior to creation, who created existence, and the characteristics of that presence. The researcher also wanted to show that the culture of Imam Ali (peace be upon him) In the book of Adam, peace be upon him, God has punished Adam (peace be upon him) for not having sinned. Because his wife is the one who fed him the fruit of the tree, and this is contrary to what was stated in the sermon of Imam (peace be upon him) who Z Adam (peace be upon him) is the one who trusted Satan and Gwighth.

We note that the approach of the rhetoric has pointed to the creation of angels and did not refer to

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Publication Date
Sat Feb 21 2026
Journal Name
Journal Of Physical Education
The Effect of Game – Like Exercises on the Development of Some Physical Abilities and Fundamental skills In Futsal
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Publication Date
Sun Jun 06 2010
Journal Name
Baghdad Science Journal
Effect of the aqueous extract of Banana Fruits Peal Musa paradisiaca on Mitosis in Plant and Mammalian cells
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The aqueous extract of banana fruits peal was tested for its effect on mitosis . The root tips of Allium cepa were used as plant test system and the bone marrow cells of the albino mice Mus musculus were used as mammalians test system in vivo .Root tips of Allium cepa were treated for four hours with five concentrations of the extract (5 , 10 , 20 , 40 ,60 mg / ml.).The Metaphase was arrested in all the treatments , the highest percentage ( 100 % ) was recorded in the first concentration , the last concentration caused stickiness and clumping of the chromosomes. The treatments did not cause significant difference in the mitotic index. The peals extract (5 mg /ml) was compared with the extracts of fruits bulb, leaves and roots of

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