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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Dec 01 2018
Journal Name
Political Sciences Journal
power and chinese Abilities development after cold war
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Abstract: This research deals with the developing of power and different abilities (military, security, economy, technology and scientific excellence) The research shows that the excellence of the Chinese economy and its development , had a positive reflection on the other powers and abilities , it means it is a base of development in all fields. The development in power and Chinese military abilities had a clear effect on Chinese strategic creed , and that what the research deals with in some details. The research also deals with developing Chinese nuclear abilities. The research doesn't ignore the security eye that indicates to the protection of the state sovereignty, concentrating on the unity and safety Chinese lands. The res

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Publication Date
Wed Jan 01 2020
Journal Name
Route Educational And Social Science Journal
THE ARAB REGION, REPERCUSSIONS AND SCENARIOS AFTER CORONA
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يمر العالم و المنطقة العربية وضعاً استثنائياً في ظل انتشار فايروس كورونا - 19 - المستحد وما تبعها من تداعيات على جميع الاصعدة في ظل تأثير تلك الجائحة وعلى شتى الاصعدة والمجالات كونها متداخلة ومترابطة معاً، ولاسيما القطاع الاقتصادي المهم الذي ينعكس بصورة مباشرة على المجالات الأخرى، لكون هذا الجانب الاساس الذي يميز المنطقة العربية فهي منطقة غنية بالموارد الطبيعية كالنفط و الغاز الطبيعي، فضلا عن الموقع الاسترا

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Publication Date
Fri Oct 28 2022
Journal Name
Political Sciences Journal
The Path of China-India Relations After 2013: Opportunities and Challenges
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China and India are considered both rising countries, and both are among the world's most populous and fastest growing economies. The long-term growth of both China and India has reinforced the importance of their bilateral relationship. The relations between China and India are complex, as relations between them have undergone great changes during the past seven decades, ranging from friendship to hostility. This study proceeds from the hypothesis that the nature and path of Sino-Indian relations after 2013 are affected by several factors and variables, some of which represent opportunities, others represent challenges and obstacles. Several opportunities have contributed to the reformulation of bilateral relations in terms of mutual ga

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Publication Date
Mon Nov 03 2025
Journal Name
Frontiers In Dental Medicine
Effects of cavity depth (moderate vs. deep with pulp exposure) on the release of prostaglandin E2 and nitric oxide in rat mandibular incisors
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Background/objectives: Inflammatory mediators such as prostaglandin E2 (PGE2) and nitric oxide (NO) are key indicators of pulp response to mechanical trauma. However, the influence of cavity depth on their release dynamics remains unclear. This study aimed to evaluate the effects of different cavity depths—moderate (without pulp exposure) and deep (with pulp exposure)—on the release of PGE2 and NO in the pulp tissue of rat mandibular incisors at two time intervals (3 and 9 h).Methods: In total, 40 male Wistar rats were divided into two main groups (n = 20) based on cavity depth. A split-mouth design was used, with cavities of different depths prepared on the left mandibular incisors, leaving the right incisors without cavities as

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Publication Date
Sun Dec 31 2000
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Preparation of Zeolite 4A and Studying the Operating Conditions of the Agglomeration in the Inclined Rotary Disk
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Publication Date
Mon Mar 08 2021
Journal Name
Baghdad Science Journal
Brucella antibod titres base line in the healthy individuals in haweja city
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152 sera were collected from healthy individuals residing A;-Haweja City were tested for antibody titers for brucella antigens by slide agglutination test

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Publication Date
Fri Jan 01 2016
Journal Name
Al-qadisiyah Medical Journal
Comparison between dome and wedge osteotomy in management of hallux valgus deformity
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Background: the condition of hallux valgus is considered as the most common deformities affecting females more than males, characteristically manifested as lateral deviation of the big toe and widening of first and second inter -metatarsal angle with a deformity of second toe in some severe cases. Objective: to make a radiological and clinical assessment of two surgical methods of osteotomy used in treatment of hallux valgu and to compare between them: first one is the distal dome osteotomy, and second one is a distal wedge metatarsal osteotomy. Patients and methods: a total of 36 feet of 28 patients suffer from hallux valgus, with mean age of 50.3 years were included in this study, followed for 6- 30 months ( mean follow-up of 8.8 months).

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Publication Date
Wed Mar 25 2020
Journal Name
Journal Of World's Poultry Research
Comparison of Weight, Components and Chemical Composition of Eggs in Guinea Fowl, Turkey, and Domestic Chicken.
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The present study was carried out to compare the physicochemical characteristics of eggs of guinea fowl, turkeys and domestic chickens outdoor reared in traditional farms in Baghdad, Iraq. A total of 166 fresh eggs; 32 eggs from guinea fowls (Numida meleagris), 44 eggs from turkeys (Meleagris gallopavo) and 90 eggs from domestic chickens; were collected. Egg weight, percentage of egg components, chemical composition (protein, lipids, and ash), and lipid profile were determined. Results revealed the significant differences in egg weight among studied birds. The average egg weights for guinea fowl, turkey, and indigenous chicken were 48.51 ± 0.72, 52.15 ± 0.74 and 61.24 ± 0.22 g, respectively. No significant differences were found in egg c

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Publication Date
Tue Apr 18 2017
Journal Name
Transactions Of The Asabe
Effect of Drying Conditions on Triticale Seed Germination and Rice Weevil Infestation
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The combination of high protein content and a soft seed coat makes the wheat-rye hybrid Triticale (Triticosecale) vulnerable to attack by rice weevils. Drying triticale grain to moisture contents safe for storage can prevent infestation by rice weevils, but if grain is being stored for seed, high drying temperatures can affect seed germination. Grain can be effectively dried at low temperatures, but low-temperature drying is difficult in hot, humid regions such as the Gulf Coast. This study nvestigated the effects of drying temperatures from 35°C to 45°C on triticale seed germination and found no statistical differences between the germination rates of the seed at any of the drying temperatures and the germination rates of controls. Final

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Publication Date
Sat Jul 01 2023
Journal Name
Journal Of Analytical Chemistry
A Spectrophotometric Method for Tetracycline Determination in its Bulk Powder and Pharmaceutical Formulations Using Flow Injection and Batch Procedures: a Comparative Study
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A reliable and environmental analytical method was developed for the direct determination of tetracycline using flow injection analysis (FIA) and batch procedures with spectrophotometric detection. The developed method is based on the reaction between a chromogenic reagent (vanadium (III) solution) and tetracycline at room temperature and in a neutral medium, resulting in the formation of an intense brown product that shows maximum absorption at 395 nm. The analytical conditions were improved by the application of experimental design. The proposed method was successfully used to analyze samples of commercial medications and verified throughout the concentration ranges of 25–250 and 3–25 µg/mL for both FIA and batch procedures, respecti

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