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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Feb 01 2018
Journal Name
Association Of Arab Universities Journal Of Engineering Sciences
Performance of composite unprotected steel Beam-deck floor exposed to high temperature (fire flame)
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An experimental program was conducted to determine the residual of composite Steel Beams-Reinforced Concrete (SB-RC) deck floors fabricated from a rolled steel beam topped with a reinforced concrete slab, exposed to high temperatures (fire flame) of 300, 500, and 700ºC for 1 hour, and then allowed to cool down by leaving them in the lab condition to return to the ambient temperature. The burning results showed that, by exposing them to a fire flame of up to 300ºC, no serious permanent deflection occurred. It was also noticed that the specimen recovered 93% of 19.2 mm of the deflection caused by burning. The recovered deflection of burned composite SB-RC deck floor at 500ºC was 40% of 77.9 mm of the deflection caused by burning with a res

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Publication Date
Sun Sep 27 2015
Journal Name
Journal Of Sustainable Development
Traditional Environmental Performance: The Impact of Active Systems upon the Courtyard House Type, Iraq
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Publication Date
Wed Nov 12 2014
Journal Name
Wireless Personal Communications
A Multi-objective Disjoint Set Covers for Reliable Lifetime Maximization of Wireless Sensor Networks
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Publication Date
Wed Mar 01 2023
Journal Name
Accounting And Financial Sciences Journal
The Extent to which the Quality of Accounting Information Systems Contributes to Reducing Material
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This research dealt with shedding light on the nature of material misrepresentations, in addition to knowing the extent to which the quality of accounting information systems contributes to reducing material misrepresentations On the theoretical side, a number of sources were relied upon in dealing with the research problem and presentation of the topic, while in the practical side, it was relied on the questionnaire form, where the research sample was (accountants and auditors), where 50 forms were distributed and 50 were received, and the data was analyzed and hypotheses tested through the program Statistical spss to show the relationship between the variables. The research reached a number of conclusions, the most important of which is t

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Publication Date
Sat Feb 01 2020
Journal Name
International Journal Of Electrical And Computer Engineering (ijece)
PSS/E based placement wind/PV hybrid system to improve stability of Iraqi grid
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<span lang="EN-US">Proper employment of Hybrid Wind/ PV system is often implemented near the load, and it is linked with the grid to study dynamic stability analysis. Generally, instability is because of sudden load demand variant and variant in renewable sources generation. As well as, weather variation creates several factors that affect the operation of the integrated hybrid system. So this paper introduces output result of a PV /wind via power electronic technique; DC chopper; that is linked to Iraqi power system to promote the facilitating achievement of Wind/ PV voltage. Moreover, PSS/E is used to study dynamic power stability for hybrid system which is attached to an effective region of Iraqi Network. The hybrid system

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Publication Date
Mon Feb 28 2022
Journal Name
Structural Chemistry
Sensitivity of SnO2 nanoparticles/reduced graphene oxide hybrid to NO2 gas: A DFT study
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Abstract<p>The sensitivity of SnO<sub>2</sub> nanoparticles/reduced graphene oxide hybrid to NO<sub>2</sub> gas is discussed in the present work using density functional theory (DFT). The SnO<sub>2</sub> nanoparticles shapes are taken as pyramids, as proved by experiments. The reduced graphene oxide (rGO) edges have oxygen or oxygen-containing functional groups. However, the upper and lower surfaces of rGO are clean, as expected from the oxide reduction procedure. Results show that SnO<sub>2</sub> particles are connected at the edges of rGO, making a p-n heterojunction with a reduced agglomeration of SnO2 particles and high gas sensitivity. The DFT results are in</p> ... Show More
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Publication Date
Sat Sep 30 2023
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Performance of Electro-Fenton Process for Phenol Degradation Using Nickel Foam as a Cathode
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Toxic substances have been released into water supplies in recent decades because of fast industrialization and population growth. Fenton electrochemical process has been addressed to treat wastewater which is very popular because of its high efficiency and straightforward design. One of the advanced oxidation processes (AOPs) is electro-Fenton (EF) process, and electrode material significantly affects its performance. Nickel foam was chosen as the source of electro-generated hydrogen peroxide (H2O2) due to its good characteristics. In the present study, the main goals were to explore the effects of operation parameters (FeSO4 concentration, current density, and electrolysis time) on the catalytic perform

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Publication Date
Sat Jan 01 2022
Journal Name
Aip Conference Proceedings
Theoretical calculation of the electronic current at N3 contact with TiO2 solar cell devices
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(3) (PDF) Theoretical calculation of the electronic current at N3 contact with TiO2 solar cell devices. Available from: https://www.researchgate.net/publication/362780274_Theoretical_calculation_of_the_electronic_current_at_N3_contact_with_TiO2_solar_cell_devices [accessed May 01 2023].

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Publication Date
Wed Aug 27 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Force decay of orthodontic elastomeric chains by using three different mechanisms simulating canine retraction
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Background: The ideal force-delivery system must: provide optimal tooth moving forces that elicit the desired effects, be comfortable and hygienic for the patient, require minimal operator manipulation and patient cooperation and provide rapid tooth movement with minimal mobility during orthodontic therapy, the elastomeric chains have the greatest potential to fulfill these requirements. Materials and Methods: This in vitro study was designed to determine the effect of three different mechanisms for canine retraction : (6-3 , 6-5-3 and chain loop ) on the load relaxation behavior of three types of elastomeric chains : (maximum clear , maximum silver and extreme silver) from the same company (Ortho Technology company) with two different bran

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Publication Date
Fri Dec 01 2017
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Suggested Model for auditing the performance of municipal institutions to verify the services provided
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The services provided by the municipal institutions of the basic things needed by the man in his daily life and the evolution of cities basically depends on these services and therefore has paid most of the world's attention to this vital facility and give him the biggest concern for the welfare of the citizens, as is the research problem that there is no program scrutiny to evaluate the performance of municipal institutions contribute to measuring the efficiency and effectiveness of the services provided and was based on research on the premise that the preparation of the existence of audit program to evaluate the performance of municipal institutions contribute to measuring the efficiency and effectiveness of services provided has reac

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