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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 05 2011
Journal Name
Baghdad Science Journal
Quantitative Analysis of Some Insecticides and Their Mixture in Agriculture by Using UV-Vis Spectrophotometer
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We studied in this research how to find a method of estimating the quantity (Kinetically) of three kinds of Insecticide and their mixture, which are used in agriculture. The extracted insecticide from the polluted samples with these insect from air, soil, and the leaves of trees, have be used into the reaction with H2O2 and benzedine. The kinetic study of this reaction was formed in basic medium,( pH= 8.6), using UV. Spectra at (?= 420nm). The study showed that the reaction is the first order, and the speed of the reaction was used to estimate the concentration of insecticide in solution and mixture. The experiments of this study indicated that this method has the speed and efficiency for quantitatively estimating these

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Publication Date
Mon Jun 15 2020
Journal Name
Al-academy
The importance of Kurdish songs and games in building the child's personality: كونا قادر محمد
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  The popular Kurdish songs and games for children are among the simplest types that can be close to the child’s interest, because we estimate that this segment is limited by its meanings and goals charged with competition and the fall of its innate biological energies, in the early years of the stages of development and growth of human mental, psychological, and muscular skills, Passionate about knowing and discovering the general decree of life, and getting acquainted with the logical rulings that surround his new law, but instinctively it approaches everything that is simple in terms of understanding and palatability, as these games and songs are simple and easy in their melodic elements and elegance Conscious and kinetic are a

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Publication Date
Mon Apr 02 2001
Journal Name
University Of Baghdad
Effect of Technology on the Relationship between Form and Structure in Contemporary Interior Space Language.
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Publication Date
Sun Sep 05 2010
Journal Name
Baghdad Science Journal
The susceptibility test of vaginal yeasts and their relationship with the age in Iraqi women
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This study aims to isolate the pathogenic yeasts from genital tract and investigate their relationship with the age .The results clarified that the most pathogenic yeast isolated from genital tract was Candida albicans , also the results of C.albicanas isolates susceptibility test, to different antifungal revealed that they were sensitive to Miconazole, Ketoconazole and Clotrimazol and were resistant to Nystatin and Grisofulvin. The study of relationship of vaginal infection with the age showed that the incidence of infection with Candida was high among females age group (19-39 years).

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Publication Date
Thu Mar 30 2006
Journal Name
College Of Islamic Sciences
The Messenger’s approach to preaching (the Meccan stage in light of the Qur’an and Sunnah)
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First: People’s need for advocacy:

Calling for a legal necessity for all people, regardless of their races, colours, tongues, and culture, to explain the truth, spread fear, bring benefits, ward off evil, regulate a person’s relationship with his Lord, and his relationship with creatures, so that he knows his money and what he owes.

All of creation is in dire need of the call to God’s religion with insight due to their inability to reach out to goodness, righteousness, guidance, and success on their own. Man is limited in thinking in this universe, limited in his resolve, unable to know what will improve his affairs in the two worlds. His need for religion is one of the necessities of his life, and one of the comple

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Publication Date
Sat Aug 01 2015
Journal Name
Journal Of Sol-gel Science And Technology
Synthesis and spectroscopic properties of silica nanoparticles as scatter centers in random gain porous media
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Scopus (3)
Scopus
Publication Date
Fri Jan 01 2016
Journal Name
Journal Of Pharmaceutical, Chemical And Biological Sciences
Relationship between Chronic Hepatitis B Virus and Pathogenicity of Celiac Disease in the Iraqi Patients
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To determine the relationship between chronic hepatitis B virus and autoimmune celiac disease, seventy five patients with chronic hepatitis B virus of ages (8-70) years have been investigated and compared with 50 healthy individuals. All the studied groups were carried out to measure antiGliadin antibodies IgA and IgG by ELISA test and anti-reticulin antibodies IgA and IgG by IFAT. There were significant elevation (P<0.05) in the concentration of AGA IgA and IgG antibodies compared to control group. The prevalence of AGA antibodies IgA and IgG was 8% and 9.33% respectively. There were a highly significant differences (P<0.01) between studies groups. The prevalence of antireticulin antibodies ARA IgA and IgG was 6.67% and 4.0% respectively i

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Impact of replacing the old chicken and add soy protein in Alvezaawih qualities Barker beef
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The purpose of this study was to determine the impact of added soy protein humidifier concentration of different ratios of bovine Alberkr mix that was to bring the old chicken shop pure beef in five ratios

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Publication Date
Wed May 17 2023
Journal Name
Journal Of The Australian Ceramic Society
Dielectric and scattering properties of transparent SiC composite in X-band range for radome application
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Publication Date
Sun Feb 22 2026
Journal Name
Euphrates Journal Of Agricultural Science
PHYSIOLOGICAL INFLUENCEOFNITROGENFERTILIZERS RESOURCESANDANTI-TRANSPIRATININ SOME QUALITY ATTRIBUTES AND THE CONCENTRATION OF NITRATES IN POTATO TUBERS
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