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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Mar 28 2008
Journal Name
Ama, Agricultural Mechanization In Asia, Africa & Latin America
The Effect of Two Type of Plows With Four Speeds on the Field Capacity and Bulk Density
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Publication Date
Thu Jan 01 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Enamel defect of primary and permanent teeth in relation to nutrients daily intake among Down's syndrome children in comparison to normal children
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Background: Any child with Down's syndrome does not develop in the same manner as normal child. Therefore, the child should not be viewed as being like everyone else. Developmental enamel defects in primary teeth have been found at least twice as frequently in disabled children as in control children. Down's syndrome consumed protein more than the recommended daily allowance compared to other disabled groups. Therefore, the aim of this study was to investigate developmental defects of enamel and their relations to nutrient intake among Down's syndrome children in comparison to normal children. Materials and Methods: A sample consisted of fifty institutionalized Down's syndrome children (study group) and 50 normal children (control group)

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Publication Date
Sat Dec 31 2022
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
EFFECT OF ADDING QUERCETIN TO TRIS EXTENDER IN SOME SEMEN CHARACTERISTICS OF AWASSI RAMS AFTER DIFFERENT PERIODS OF CRYOPRESERVATION: EFFECT OF ADDING QUERCETIN TO TRIS EXTENDER IN SOME SEMEN CHARACTERISTICS OF AWASSI RAMS AFTER DIFFERENT PERIODS OF CRYOPRESERVATION
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ABSTRACT

The study evaluated the effect of adding quercetin to some characteristics of the sperm of the ram. This study was conducted in the animal field, Department of Animal Production, College of Agricultural Engineering Science, University of Baghdad for the period 5/12/2021 to 20/2/2022. In this experiment, 3 rams were used at the age of 2-2.5 years and weighed 50-55 kg. The semen was collected early in the morning and once a week and the semen was pooled to remove the individual differences. The treatments were divided: quercetin-free control group, treatment T1 (3 µL/mL quercetin), T2 treatment (6 µL/mL quercetin), T3 treatment (9 µL/mL quercetin). The result of the study showed

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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
China's Middle East policy after 2001
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The foreign policy of china is considered an important subject generally, in addition its very significant towards the Middle East specifically. It is the most valued topic, that needs deep academic investigations in order to identify the important factors causes and its consequences, this kind of research provides a proper understanding to the researchers and politicians, it will prove the reasons for China's with the impact to the region, the rivalry with the United States in the coming years

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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
The Iraqi- Kuwaiti relations after 2003
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The Iraqi- Kuwaiti relations had witnessed a lot of problems which had its impact on them, at the fore front is the frontier issue, and the Iraqi invasion of Kuwait in 1990 which led to the severance of relations between them and had strengthened the disagreement and the dispute and raised the animosity and tension.
After 2003, Iraq has witnessed a lot of changes which affected Iraq and the region as a whole.
Under the new political developments in Iraq, a now phase has started in the relations between the two parts. which is based on the emphasis on building new relations based on the mutual respect and non intervention in the internal affairs of both countries, and in accordance with the principles of the international law, and w

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Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
American - Irani Relations after Nuclear Agreement
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Summary

The fundamental turning point in American policy towards the Iran was the success of the Islamic revolution in Iran 1979 . Since than U S policy has been hostile to Iran . After the events 11 September 2001 , there was an American idea of dialogue with some countries opposed to US policy , including Iran . In 2004 the United States launched the Greater Middle East project , which contain a range of political , economic and cultural proposals for the region , all of which were in the interest of the United States and ( Israel ) , which Iran opposed . The failure of U S projects in region prompted the United States to agree with Iran on the nuclear file . On 8 May 2018 U S President Donald Trump of

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Publication Date
Thu Jan 01 2026
Journal Name
Technical University Of Munich
Conditions for Applying Public Private Partnership PPP in Iraq Infrastructure Projects Successfully
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Public private partnership PPP is a method to procure public projects in order to achieve additional value for money in terms of efficiency and quality of services. This thesis studies the concepts of PPP, advantages and disadvantages of PPP. In addition, current Iraq infrastructure projects situations and needs, as well as, some aspects relating to the Iraq’s construction market, legal and contract systems were discussed. A financial model was carried out and applied to a real-life case study project. Finally, a survey targeted researchers; public and private- sectors were applied.

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Publication Date
Mon Jul 01 2013
Journal Name
Journal Of Kerbala University
study the optimum conditions of synthesis AgNP by chemical reduction method
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Abstract :- In this paper, silver nanoparticles had been prepared by chemical reduction method. Many tests had been done to it such as UV-Visible spectrophotometer, XRD, AFM&SEM test. finally an attempt had been done to get the optimum condition to control the grain size of silver Nanoparticles by variation the heating period and other parameters which has an effect in silver Nanoparticles synthesis process. in this method we can get a silver nanoparticles in the size range from 52 to 97 nm.

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Publication Date
Fri Sep 15 2023
Journal Name
Bionatura
A comparison of VCAM-1 and ICAM-1 as atherosclerosis risk factors in patients with systemic lupus erythematosus from Iraq
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All major organs may be impacted by the connective disease systemic lupus erythematosus, a separate risk factor for coronary artery disease (CAD). Adhesion molecules like intercellular adhesion molecules (ICAM) and vascular cell adhesion molecules (VCAM) can detect endothelial damage and dysfunction, which appear to play a crucial role. This study investigated whether people with SLE had elevated subclinical and clinical atherosclerosis risk factors. Traditional CAD risk factors such as smoking, hypertension, and hyperlipidemia cannot entirely explain this elevation. It is thought that immunological dysfunction also increases CAD risk in SLE patients. The study aimed to assess early endothelial changes in SLE Iraqi female patients w

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Publication Date
Tue Oct 04 2022
Journal Name
International Journal Of Dentistry
Comparison between Rolled and Nonrolled U-Shaped Flap in the Second Stage of Dental Implant Surgery: A Randomized Clinical Trial
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Background. The presence of black triangles around the dental implant-supported prosthesis and the failure to construct adequate papillae around them bothers dental implantologists. Peri-implant surgical soft tissue management will improve esthetics, function, and implant survival. Aim. To compare the effects of rolled and nonrolled U-shaped flaps combined with a temporary crown in enhancing the soft tissue around dental implants. Materials and Methods. Forty patients were included in this study; all patients were operated on by the same maxillofacial surgeon at Al-Iraq specialized dental clinics from January 2019 to January 2020. Patients were divided randomly into two groups: group A: at the second stage of implant surgery, a U-sh

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