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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Aug 31 2021
Journal Name
Iraqi Geological Journal
Structural Interpretation of Yamama and Naokelekan Formations in Tuba Oil Field Using 2D Seismic Data
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This research includes structure interpretation of the Yamama Formation (Lower Cretaceous) and the Naokelekan Formation (Jurassic) using 2D seismic reflection data of the Tuba oil field region, Basrah, southern Iraq. The two reflectors (Yamama and Naokelekan) were defined and picked as peak and tough depending on the 2D seismic reflection interpretation process, based on the synthetic seismogram and well log data. In order to obtain structural settings, these horizons were followed over all the regions. Two-way travel-time maps, depth maps, and velocity maps have been produced for top Yamama and top Naokelekan formations. The study concluded that certain longitudinal enclosures reflect anticlines in the east and west of the study ar

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Publication Date
Mon Feb 21 2022
Journal Name
Научный форум: Филология, искусствоведение и культурология: сб. ст. по материалам Lvi междунар. науч.-практ. конф. – No 2 (56). – М
Comparative analysis of zoomorphic metaphors in Russian and Arabic as a method for studying linguoculturology
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: zonal are included in phraseological units, form metaphorical names for a person, give him various emotional and evaluative characteristics. This article examines the topic of zoomorphic metaphors that characterize a person in the Russian and Arabic languages in the aspect of their comparative analysis, since the comparative analysis of the metaphorical meanings of animalisms is an important method for studying cultural linguistics, since zoomorphic metaphors are a reflection of culture in a language.

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Publication Date
Fri Jan 01 2021
Journal Name
Indian Journal Of Forensic Medicine & Toxicology,
Role of CoQ10 and IGFBP-1 in Obese Male Patients with Diabetic Mellitus Type II
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Study the role of CoQ10 and IGFBP-1 in obese male patients with diabetic mellitus type 2. ELISA method was used to assay Serum CoQ10 and IGFBP-1. Blood was taken with drawn sample from 30 obese normal patients with age range (40-60) years, 30 diabetic patients with age range (40-60) years at duration of disease (1-5) years and 30 normal healthy patients. The mean difference between T2DM according to CoQ10 (12.5±1.1) was decreased than the mean of IFG (21.8±3.2) (P 0.002) and the mean difference between T2DM according to IGFBPs (0.65±0.06) was decreased than the mean of IFG (3.2±0.3) (P 0.000). While no significant difference between mean age of DM2 patients (55.5±1.06), and IFG (55.6±0.9) (p 0.90), no significant difference bet

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Publication Date
Sat Mar 01 2025
Journal Name
European Journal Of Ecology, Biology And Agriculture
Molecular Characterisation of Virulence Factors in Cryptococcus spp. Isolated from Humans, Pigeons, and Eucalyptus Sources
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This study aimed to isolate and identify Cryptococcus species from three distinct sources: sputum samples of pigeon fanciers, dried pigeon droppings, and eucalyptus tree leaves. A total of 150 specimens were collected over a two-month period, comprising 50 samples each from human sputum, pigeon droppings collected across various areas of Baghdad, and eucalyptus leaves obtained from the Baghdad College of Veterinary Medicine. All samples were cultured on Sabouraud dextrose agar supplemented with chloramphenicol and incubated at 25°C for 2–3 days. From the initial cultures, 20 isolates presumptively identified as Cryptococcus spp. were obtained: 6 isolates (12%) from human sputum, 9 isolates (18%) from pigeon droppings, and 5 isol

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Publication Date
Fri Jun 16 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Clinical significance of Osteoprotegerin, Vitamin D, Obestatin and some biochemical variables in Kidney failure Patients
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Chronic kidney disease (CKD) is described as an abnormalities of renal function, existing for a long period of time. By reason of the early grades of Chronic kidney disease can be experiences no symptoms, its premature identification is strenuous. initial stage CRD can cause various complications, such as anemia, matabolyic disorders of bone mineral. The study was done to assess the effect the chronic renal disease stage on the Osteoprotegerin, 1,25 dihydroxyvitamin D, Obestatin levels and some biochemical parameters in patients not undertaken dialysis therapy. In this case-control study fifty-five patients with Kidney failure and fourty healthy people were examined. Circulating concentrations of Osteoprotegerin, 1,25 dihydroxyvitamin D

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Publication Date
Wed Mar 01 2023
Journal Name
International Journal Of Nonlinear Analysis And Applications
The use of ARIMA, ANN and SVR models in time series hybridization with practical application
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Forecasting is one of the important topics in the analysis of time series, as the importance of forecasting in the economic field has emerged in order to achieve economic growth. Therefore, accurate forecasting of time series is one of the most important challenges that we seek to make the best decision, the aim of the research is to suggest employing hybrid models to predict daily crude oil prices. The hybrid model consists of integrating the linear component, which represents Box Jenkins models, and the non-linear component, which represents one of the methods of artificial intelligence, which is the artificial neural network (ANN), support vector regression (SVR) algorithm and it was shown that the proposed hybrid models in the predicti

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Publication Date
Thu Sep 15 2022
Journal Name
Journal Of Baghdad College Of Dentistry
Serum ferritin level and B12 in a sample of Iraqi re-current aphthous stomatitis patients
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Background: Recurrent aphthous stomatitis (RAS) is one of the most common oral mucosal disorders with a prevalence of 50-66%. The prevalence of hematinic deficiencies including ferritin and vitamin B12 deficiencies and their role in the prophylaxis and development of RAS is not well known. Many studies have demonstrated a high prevalence of hematinic deficiencies in patients with RAS. This study aimed to compare the serum level of ferritin and vitamin B12 in patients with recurrent aphthous ulcers and healthy controls. Subjects, Materials and Methods: The data were collected from patients who needed blood analysis to exclude anemia from November 2020 to May 2021. The study was approved by the institutional ethics committee. After recordi

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Publication Date
Tue Jun 01 2021
Journal Name
Al-khwarizmi Engineering Journal
Modeling and Simulation for Performance Evaluation of Optical Quantum Channels in Quantum key Distribution Systems
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In this research work, a simulator with time-domain visualizers and configurable parameters using a continuous time simulation approach with Matlab R2019a is presented for modeling and investigating the performance of optical fiber and free-space quantum channels as a part of a generic quantum key distribution system simulator. The modeled optical fiber quantum channel is characterized with a maximum allowable distance of 150 km with 0.2 dB/km at =1550nm. While, at =900nm and =830nm the attenuation values are 2 dB/km and 3 dB/km respectively. The modeled free space quantum channel is characterized at 0.1 dB/km at =860 nm with maximum allowable distance of 150 km also. The simulator was investigated in terms of the execution of the BB84 prot

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Publication Date
Sun Sep 07 2014
Journal Name
Baghdad Science Journal
Effect of Alcoholic Catechin Extract on Hyperglycemia, Hyperlipidemia and Liver Functions in Alloxan Diabetic Mice
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The objective of this study is to estimate the effect of the hydro-ethanolic catechin extract toward blood glucose, lipid profile and liver functions in alloxan diabetic mice. 50 healthy mice (25-30 g) were divided into five groups of ten animals for each. Group A received normal saline as normal control group. To induce diabetes, alloxan (150 mg/kg), intraperitoneal (i.p.) single dose was injected to groups B, C, D and E. Group B represents diabetic control group. Groups C, D and E received ethanolic catechin extract (30 mg/kg and 40 mg/kg) for different periods of 1, 2 and 3 weeks as treated groups. Blood glucose, serum lipids [Total Cholesterol (TC), Triglycerides (TGs) and High Density Lipoproteins (HDL)], asparagine transaminase (AST),

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Publication Date
Thu Sep 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
HRA and its Impact on Employees Performance: A Field Research in the Ministry of Education
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          The research aims to determine the impact of Human Resources Accounting (HRA) on employee’s performance. The research’s problem was embodied in the lack of interest in HRA, which was reflected on the performance of employees in the Ministry of Education; the research adopted the descriptive-analytical approach, and the research community included the directors of departments and people at the headquarters of the Ministry of Education. The sample size was (224) individuals from the total community of 533. The questionnaire was adopted as the main tool for collecting data and information, as well as the interviews that were conducted by the researcher. In order to analyze t

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