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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 01 2023
Journal Name
Baghdad Science Journal
Comparison Study between Adipsin Levels in Sera of Iraqi Patients with Diabetes and Neuropathy
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The current study was designed to compare some of the vital markers in the sera of diabetic and neuropathy patients via estimating Adipsin, Fasting blood Glucose(FBG), Glycated(HbA1c) hemoglobin, Homeostasis Model Assessment Index (Homa IR ), Cholesterol, High density lipoprotein (HDL), Triglycerides (T.G), Low-density, and lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), in sera of Iraqi patients with diabetes and neuropathy. A total  of ninety  subjects  were divided into three groups: group I (30 diabetic with neuropathy males) and group II (30 diabetic males without neuropathy), and 30 healthy sujects were employed as control group. The results showed a significant decline in Adipsin levels (p>0.05) in neuropathy, T2DM g

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Publication Date
Fri Oct 20 2023
Journal Name
Bmc Endocrine Disorders
Dietary caffeine intake is associated with favorable metabolic profile among apparently healthy overweight and obese individuals
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Abstract<sec> <title>Background

Recent studies have revealed some conflicting results about the health effects of caffeine. These studies are inconsistent in terms of design and population and source of consumed caffeine. In the current study, we aimed to evaluate the possible health effects of dietary caffeine intake among overweight and obese individuals.

Methods

In this cross-sectional study, 488 apparently healthy individuals with overweight and obesity were participated. Dietary intake was assessed by a Food Frequency Questionnaire (FFQ) and

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Publication Date
Sat Aug 02 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Estimation of soluble CD14 level in saliva of patients with different periodontal conditions and its correlation with periodontal health status
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Background: Cluster of differentiation 14 (CD14) is a serum/cell surface glycoprotein; and it is a pattern recognition receptor. CD14 expressed on the surface of various cells, or it found soluble in saliva and other body fluids. It has been proposed that soluble CD14 (sCD14) may play a protective role by controlling Gram negative bacterial infections through its capacity to bind lipopolysaccharide. This study was conducted to assess the level of soluble CD14 in saliva of patients with different periodontal diseases and healthy subjects and determine its correlation with clinical periodontal parameters. Materials & Methods: A total of 80 subjects, age ranged (25-50) years old, divided into three main groups, group ? consisted of 45 chronic

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Publication Date
Mon Apr 01 2024
Journal Name
Academic Science Journal
Comparison between MDDV and VADD routing protocols in VANET (Case Study)
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Routing is the process of delivering a packet from a source to a destination in the network using a routing algorithm that tries to create an efficient path. The path should be created with minimum overhead and bandwidth consumption. In literature, routing protocols in VANET were categorized in many ways, according to different aspects. In the present study, we prefer the classification based on the number of hops to reach the destination node. In literature, these are single-hop and multi-hops protocols. We first discuss the two types and then compare the MDDV (multi-hops protocol) with VADD (single-hop protocol). The comparison is theoretically and experimentally implemented by providing a network environment consisting of SUMO, VIENS and

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Publication Date
Sat Jan 13 2018
Journal Name
Journal Of Engineering
Comparison Between ESP and Gas Lift in Buzurgan Oil field/Iraq
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Buzurgan oil Field which is located in south of Iraq has been producing oil for five decades that caused production to drop in many oil wells. This paper provides a technical and economical comparison between the ESP and gas lift in one oil well (Bu-16) to help enhancing production and maximize revenue. Prosper software was used to build, match and design the artificial lift method for the selected well, also to predict the well behavior at different water cut values and its effect on artificial lift method efficiency. The validity of software model was confirmed by matching, where the error difference value between actual and calculated data was (-1.77%).

The ESP results showed the durability of ESP regarding th

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Publication Date
Sat Dec 01 2018
Journal Name
Future Dental Journal
Studying some mechanical properties of maxillofacial silicone elastomer before and after incorporation of intrinsic pigments and artificial aging
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Objective Advantageous properties of silicone elastomer made it one of the favorable materials in maxillofacial prosthesis construction, but these properties may change after months of usage or after pigments addition. This study aimed to define the optimum concentration for a mixture of two types of intrinsic pigments that added to VST-50 maxillofacial silicone material and study their effects on mechanical properties before and after artificial aging. Methods After the pilot study was conducted, 0.1% by weight of rayon flocking and 0. 2% by weight of burnt sienna intrinsic pigment concentration was selected because of improvement in tested mechanical properties of VST-50 maxillofacial silicone. A total of one hundred and eighty samples we

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Publication Date
Sun Jul 02 2017
Journal Name
Journal Of Educational And Psychological Researches
Prevalence of Posttraumatic Stress Symptomatology and Distribution of Attachment Patterns 1 and 5 Months after a Terrorist Attack
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As a consequence of a terrorist attack, people may experience posttraumatic stress disorder (PTSD) and lack of feeling secure in relationships. This longitudinal study aimed to examine the prevalence of PTSD symptoms over time, the relationship between adult attachment styles and PTSD, as well as their association with degree of exposure, and finally to consider the distribution and the trajectory of attachment styles. The sample consisted of 235 students (M=125, F=110) who were exposed to different levels of trauma intensity in response to a bombing attack. Participants were recruited and assessed approximately 1 month and 5 months after the attack using a battery of questionnaires. Findings revealed, as expected, that 79.5% of the part

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Publication Date
Tue Dec 30 2008
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Effect of operation conditions on Catalytic Oxidation of Phenol in Aqueous Solution
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This work was conducted to study the oxidation of phenol in aqueous solution using copper based catalyst with zinc as promoter and different carrier, i.e. γ-Alumina and silica. These catalysts were prepared by impregnation method.
The effect of catalyst composition, pH (5.6-9), phenol to catalyst concentration ratio (2-0.5), air feed rate (30-50) ml/s, stirring speed (400-800) rpm, and temperature (80-100) °C were examined in order to find the best conditions for phenol conversion.
The best operating conditions which lead to maximum phenol conversion (73.1%) are : 7.5 pH, 4/6 phenol to catalyst concentration, 40 ml/s air feed rate, 600 rpm stirring speed, and 100 °C reaction temperature. The reaction involved an induction period

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Publication Date
Mon Jan 01 2018
Journal Name
International Journal Of Science And Research
Comparison of Bacterial Contamination between I Phone and Galaxy Devices
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Ninety eight mobile samples, (54) galaxy phone and (44) I phone, were swabbed for bacterial culture determination by culturing on MacConky agar , Blood agar , Mannitol salt agar , Muller Hinton agar .Staphylococcuswas the highest frequent isolated bacteria from Galaxy phone (33%) and I phone (37%). This study revealed that galaxy phone appears less contaminated with bacteria, the ratio of non-contaminated devices is (44%) when compared with I phone (9%). Sensitivity test showed that Ogmintin have the lowest effect on Staphylococcusisolated from both type of devices while cefitriaxone have the highest effect. DNA of isolate from galaxy 31 that exhibit highest resistance against antibiotics was extracted and 16S rRNA gene was polymerized by P

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Publication Date
Fri Dec 25 2020
Journal Name
Al-nahrain Journal For Engineering Sciences
Comparison Sequences of Pick and Place System Controlled Using PLC
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Pick and place system is one of the significant employments of modern robots utilized in industrial environments. The objective of this research is to make a comparison of time sequences by combining multiple axes of sequences. A pick-place system implemented with pneumatic linear double-acting cylinders to applicator in automated systems processes for manufacturing. The challenge of 3-axes movement control was achieved using the PLC (Programmable Logic Controller) controller such that the merging between two or three axes was achieved according to the selected sequence of the program. The outcomes show the contrasted sequences and the reference in a constant velocity. The main variable parameter is the number of steps for each sequ

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