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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 15 2010
Journal Name
Iraqi Journal Of Laser
Evaluation the Effect of 805 nm Wavelength Diode Laser on Repair of Mandibular Bone Repair and Skin Incisions in Rabbits
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The long healing time of bone after tooth extraction in order to construct artificial teeth is uncomfortable to the patient because of aesthetic or masticatory problems in addition to the daily visit to dental clinic. The objective of this study was to evaluate the effect of 805 nm diode laser with long time intervals on repair of bone and skin incisions in rabbits through biochemical, radiological and histological findings. Eighteen New-Zealand rabbits were undergone surgical operations to make a cavity in the bone of the lower jaw, the rabbits were divided into two groups:- Group A (control group) containing nine rabbits. Group B (lased group) containing nine rabbits in which two cavities were done, one on the right side and the other

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Publication Date
Fri Dec 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Influence of Water Stress on Expression of the X95950 Gene and Several Cellular Callus Components in Violet-Treated Sunflower Varieties
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Abstract<p>The research was conducted between 2017 and 2019 at the College of Agricultural Engineering Sciences and Laboratory of Plant Tissue Culture for Postgraduate Studies at the University of Baghdad. One experiment used a totally random design. The experiment examined the effects of PEG (Polyethylene glycol) at concentrations of 0, 2, 4, 6, and 8% on the development of three sunflower types (Ishaqi<sup>-1</sup>, Aqmar, and AL-Haja) exposed to UV-C rays for 40 minutes as a result of the growing of the juvenile peduncle outside the live body. The aim of the study was to better comprehend the physiological and biochemical changes caused by water stress on the callus of several sunfl</p> ... Show More
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Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
The mediator role of the psychological contract in light of the linking between training needs and organizational commitment - exploratory search
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  The purpose of this research shed light on the analysis of the relationship between training needs and organizational commitment and the role of a variable contract psychological, and start search of a dilemma thought provoking fundamental questions revolve around the search was the answer to all those questions of tricks theoretical framework to the variables of research first and test models of the relationship and impact secondly During six hypotheses major, The objective of the research the impact of the factors that affect training needs in organizational commitment center the psychological contract, and applied research on a sample of 100 individuals working in the engineering department and maintenance at the D

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Publication Date
Tue Feb 08 2022
Journal Name
Political Sciences Journal
The role of variables contact for non-state actors and opposite forces of civil social in ensuring the social peace
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Receipt date:6/3/2021  acceptance date:4/5/2021 Publication date:31/31/2021

Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License.

The research in the role of variables contact for non-state actors have become more influential in the current of contemporary events, that related with the reality of seeking services and providing all of that in favor of maintaining the social peace, and ensuring its empowerment in order to make peace and stability outcomes as a real fa

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Publication Date
Mon Jan 01 2024
Journal Name
Brazilian Dental Science
Antimicrobial activity of Er,Cr:YSGG and Ultrasonic on E. faecalis biofilm in the mesial root canal systems of lower molars
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Publication Date
Thu Feb 29 2024
Journal Name
International Journal Of Design &amp; Nature And Ecodynamics
Artificial Neural Network Assessment of Groundwater Quality for Agricultural Use in Babylon City: An Evaluation of Salinity and Ionic Composition
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Publication Date
Sat Oct 01 2011
Journal Name
Baghdad Science Journal
Studying the Effect of Aqueous Extract from Curcuma Longa on Some Parameters of Cytogenetic, Immunity and Fertility in Female Mice
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The research work was conducted to investigate the effect of oral administration of aqueous extract of turmeric at doses of (5, 10) mg/kg body weight for two weeks daily by determining the genotoxic effect (mitotic index), evaluation of immunological effect (IgG, IgM, IgA, C3, C4) and measuring fertility hormones (follicles stimulation hormone/FSH, lutenising hormone/LH) levels with histological examinations of female albino swiss mice ovaries in comparison with control (normal saline). A clear effect in increasing mitotic activity was reveled for both doses in comparison with control. Results also showed a significant increase in the value of all immunological parameters at both doses, in comparison with control. Also, obvious raise was se

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Publication Date
Tue Aug 23 2022
Journal Name
International Journal Of Health Sciences
Effect of Using Fryer strategy on the achievement and systemic thinking of intermediate second class students in the chemistry subject.
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The objective of this research is to identify the effect of Using Fryer strategy on achievement and systemic thinking in the subject of chemistry of second class intermediate school students. The sample of research consisted of 59 students in one intermediate school in Baghdad/Iraq, split into two groups; experimental and control. The scientific material of the study is related to Chapters II and III of the Science Book for the second Intermediate School for the Year (2019-2020). The scientific test is composed of 25 test items whilst the second instrument for research related to systematic thinking test consisted of 12 items. The results of the research showed that the use of Fryer's chemistry-teaching strategy has increased achieve

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Publication Date
Thu Jan 02 2020
Journal Name
Journal Of The College Of Languages (jcl)
The personality of the woman and her role in the products of Agnon: דמותה ותפקידה של האישה ביצירותיו של עגנון
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  Shmuel Yosef Agnon, a well-known Jewish writer, wrote many literary works, including poetry, story, etc. In the field of story, this writer used two areas: the first: a simple exterior, and the second: an inner full of secrets and mysteries. This area is common when Agnon is affected by his symbolic method of purpose. In his productions, we find the political and historical significance embodied in his characters, where there is almost no story without it.

    Agnon and all his productions gave the character a large area, Agnon’s characters often play the center and cornerstone in those productions, where the author dealt deeply and stated the fines details of the external and internal of that ch

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Publication Date
Wed Mar 04 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Mesio-distal crown dimension of permanent dentition in normal, crowding, and spacing of young adult sample aged 18-25 years
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Background: This study aimed to assess the effect of tooth width in malocclusion in relation to normal, crowding, and spacing dentition. Materials and methods: The sample included dental casts of some dental students and orthodontic patients; their age was (18-25) years and having three groups normal, crowding, and spacing dentition groups. The sample was equally divided to three groups normal, crowding, and spacing dentition groups, each group contained 50 maxillary and 50 mandibular casts that were further subdivided by gender; all the stone casts were measured by highly sensitive digital vernier. Results and Conclusions: Non-significant side difference was found in both dental arches in the three studied groups. Males had higher mesiodis

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