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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 May 21 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Effect of ginger extract on Mutans streptococci in comparison to chlorhexidine gluconate
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Background: The rhizome of ginger is used in cooking and for medicinal purposes such as anti-bacterial, anti-fungal, anti-inflammatory and antioxidant. The aims of the study were to test the effect of ethanolic extract of ginger on growth, adherence and acidogenicity of mutans streptococci in comparison to chlorhexidine gluconate 0.2% and de-ionized water. Materials and methods: From saliva often volunteers (dental students 20-22 years); mutans streptococci was isolated, purified and diagnosed according to morphological characteristic and biochemical tests. Ginger was powdered and extracted, different concentrations of ginger extract were prepared. Chlorhexidine gluconate 0.2% used as a control positive; while de-ionized water was used as a

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Publication Date
Tue Jan 01 2008
Journal Name
J Bagh College Of Dentistry
A comparative study of the sealing ability of two different obturation techniques with and without the use of sealers.
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Background: The final stage of endodontic therapy is complete obturation of the root canal system to provide as perfect as possible at the cementodentinal junction of the apical foramen. The purpose of this in vitro study was to evaluate the sealing ability of injection molded thermoplasticized gutta percha and lateral condensation techniques with and without the use of sealers. Materials and Methods: Forty freshly extracted adult human maxillary central incisors with complete formed apices were utilized in this study. The teeth were randomly divided into four groups for evaluation of the apical seal. Group (1) lateral condensation gutta percha technique without sealer, (2) lateral condensation gutta percha technique with sealer, (3) Inject

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Publication Date
Tue Sep 27 2022
Journal Name
Journal Of Positive School Psychology .
The Explosive Capacity Of The Muscles Of The Two Men And Their Relationship To The Scoring Of Football Halls
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The research dealt with its forefront a definition of the aspects of the study and its variables, the explosive capacity and its relationship to the scoring of football for the halls and highlights the importance of these variables, and the problem of the research consisted that some players fail to score Amie because of the weak power of shots or the slow scoring, so the researchers saw studying this problem and knowing the extent of the influence of the explosive strength During the performance of the skill of scoring with five football, the study aimed to identify the relationship between the explosive strength and the skill of scoring with five football. Researchers assume that there is a statistically significant relationship between t

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Publication Date
Sun Feb 10 2019
Journal Name
Journal Of The College Of Education For Women
The Egyptian-Ethiopian Relations after the Change
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Egypt and Ethiopia have connected in a strong relation as there are historical facts that
deepen these relations, one of these is Egypt's cooperation in establishing the first economic
and financial banking system in Ethiopia.
Beside the religious relation between The Egyptian and Ethiopian churches the Nile River is
considered one of the effective connections
That strong then the relations as it leads to some tension between the two countries because
Ethiopia believes that Egypt seeks to control the river tries to build its project over the Blue
Nile means a threat to the Ethiopian national security.
The tension continues even after the revolution of 25th of January 2011because the Nahda
dam which is a clear t

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Publication Date
Sun Dec 27 2020
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Evaluation the profitability of public commercial banks using liquidity indicators: A comparison of the Rafidain and Rasheed study
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The issue of liquidity, profitability, and money employment, and capital fullness is one of the most important issues that gained high consideration by other authors and researchers in their attempts to find out the real relationship and how can balance be achieved, which is the main goal of each deposits.

For the sake of comprising the study variables, the research has formed the problem of the study which refers to the bank capability to enlarge profits without dissipation in liquidity   of the bank which will negatively reflect on the bank's fame as well as the customers' trust. For all these matters, the researcher has proposed a set of aims, the important of which is the estimation of the bank profitability; liquid

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Publication Date
Tue Jun 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of weighted estimated method and proposed method (BEMW) for estimation of semi-parametric model under incomplete data
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Generally, statistical methods are used in various fields of science, especially in the research field, in which Statistical analysis is carried out by adopting several techniques, according to the nature of the study and its objectives. One of these techniques is building statistical models, which is done through regression models. This technique is considered one of the most important statistical methods for studying the relationship between a dependent variable, also called (the response variable) and the other variables, called covariate variables. This research describes the estimation of the partial linear regression model, as well as the estimation of the “missing at random” values (MAR). Regarding the

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Publication Date
Mon May 29 2023
Journal Name
Rawal Medical Journal
Comparison of functional and radiological outcomes of lower third closed tibia fractures treated by nail VS plate osteosynthesis
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Objective: To determine the functional and radiological outcomes of lower third tibia closed fractures fixed by nail or plate osteosynthesis. Methodology: This randomized controlled trial included 20 patients presenting with closed fracture lower third tibia in Al-Kindy teaching hospital, Baghdad, Iraq. The patients were divided as every other one into two equal groups; group I had fractures fixed by 3.5 mm locked plate and group II by intramedullary locking nail. We followed all patients for 24 weeks to assess surgical complications, fracture union, alignment and functional outcome based on Knee society score (KSS). Results: The mean union time in both groups was 10.2 ± 1.48 and 9.3 ± 1.77 weeks, respectively (p = 0.003). Mean KSS in bot

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Publication Date
Thu Nov 21 2024
Journal Name
F1000research
Comparison of the severity of urinary tract infections between Metformin and SGL2 Inhibitors among Iraqi Type 2 Diabetics.
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Background Many antidiabetic medications with distinct modes of action are available, The sodium glucose cotransporter-2 (SGLT-2) inhibitors are among the most recent oral antihyperglycemic medications. The American Diabetes Association recommends metformin, a biguanide medication, as the first option for oral control of type 2 diabetes because it has demonstrated promise in this regard. Aim of the study To evaluate and compare the effects of metformin and SGLT-2 inhibitors on general urine parameters in T2DM patients from Iraq. Method a prospective cohort study where 101 adult patients of both sexes aged under 70 years and newly diagnosed with T2DM, patients were divided into two groups, Metformin group (n=52), where metformin was p

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Publication Date
Fri Dec 25 2015
Journal Name
Iraqi Dental Journal
Comparison of Some Mechanical Properties of Silanated SiO2 and Polyester Fiber Composite Incorporation into Heat Cured Acrylic Resin.
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Publication Date
Sat Jan 01 2022
Journal Name
Revista Iberoamericana De PsicologÍa Del Ejercicio Y El Deporte
THE EFFECT OF TRAINING NETWORK TRAINING IN TWO WAYS, HIGH INTERVAL TRAINING AND REPETITION TO DEVELOP SPEED ENDURANCE ADAPT HEART RATE AND ACHIEVE 5000 METERS YOUTH
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