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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Dec 25 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Impact of Two Doses of Vitamin K2 (Menaquinone-7) on Doxorubicin-Induced Hepatotoxicity in Rats
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The objective of this study was to evaluate the impact two doses of Menaquinones-7 on hepatotoxicity induced by doxorubicin in rats. Sixty adult rats of both sexes were used in this study; the animals were randomly enrolled into six groups of 10 animals each. Group I: negative control (rats administered distilled water); Group II: Menaquinones-7 at a dose of  16 µg/kg; Group III: Menaquinones-7 at a dose of 48 µg/kg; Group IV: positive control (Doxorubicin 15 mg/kg); Group V: Menaquinones-7 at a dose of 16 µg/kg administered prior to a single dose of Doxorubicin 15 mg/kg; Group VI: Menaquinones-7 at a dose of 48 µg/kg administered prior to a single dose of  Doxorubicin 15 mg/kg. On day twelve of the study, blood was

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Publication Date
Tue Aug 18 2020
Journal Name
Journal Of Mechanics Of Continua And Mathematical Sciences
THE COMPARISON OF THE METHODS ESTIMATING THE FRACTIONAL DIFFERENCES OF PARAMETER AND ITS DEPENDENCE ON ESTIMATION THE BEST LINEAR MODEL OF TIME SERIES IN THE ENVIRONMENTAL FIELD
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Publication Date
Sun Aug 18 2019
Journal Name
Political Sciences Journal
The challenges of precision axes for futuristic regional relations in the middle east (Iraq after post triumph's period)
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The research has tackled about an important transformation within the whole region of middle east, especially there were more challenges which revealed under the huge pivotal interests of global powers that ruled the new world order by United states of America ; being very affected over the international and regional relations than any situations appeared previously within political realities. So that, many of variables inside the international scene which happened during of this period of contradicting strategic policies by the process of reforming and restructuring of difficult equations that imposed by international and regional allies and blocs . This article had concentrated over various strategic and political studies which reflect

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Publication Date
Tue Jan 20 2026
Journal Name
Sciences Journal Of Physical Education
Cognitive bias and its relationship to the performance of the two skills of standing on (hands and the human wheel) on the floor movement carpet device in the artistic gymnastics for women
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Publication Date
Fri Aug 26 2022
Journal Name
Surgical Neurology International
Excellent recovery after nonmissile penetrating traumatic brain injury in a child: A case report
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Background:

Nonmissile penetrating traumatic brain injuries (pTBIs) are low-velocity injuries which can be caused by a variety of inflicting tools and represent a rare entity in children. Poor outcome has been attributed with an initial admission Glasgow Coma Scale (GCS) of <5, asymmetrical pupil size, and specific initial computed tomography scan findings including brainstem injury.

Case Description:

We report a case of an 11-year-old boy who presented to our ER with a GCS of 6 after being assaulted on his head by a 30 cm length metallic tent hook penetrating his forehead reaching down to the central skull bas

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Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
Soft power employment strategy in foreign affairs (Eygpt after Mubarak Regime : An Analytical study)
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(January 25, 2011) represented a real opportunity to bring about fundamental changes in Egyptian foreign policy and to start a new phase that would cut off all the negative and problematic aspects of Egyptian politics in the period before the revolution. Through the employment of Egypt's huge balance and the role of historical is a civilization rooted in the roots of thousands of years and Islamic reference represented over more than a thousand years the Islamic medium of religion in the start of vision and tools to achieve the Egyptian national interest, and safeguarding Egyptian national security in its comprehensive sense. The research attempts to answer a central question: Is there a role for Egyptian soft power in the Islamic world

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Publication Date
Sun Mar 02 2008
Journal Name
Baghdad Science Journal
He-Ne Laser Irradiation Encourages reparative processes After cartilage loss in New Zealand rabbits
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Many therapeutic methods used to encourage reparative processes of cartilage and accelerate their healing such as drugs, magneto-laser and so on. Twenty four adult New Zealand rabbits used in this study. They were divided in to two groups; control and treaded with He –Ne laser. A square skin flap done on the medial aspect of both auricles followed by pealing a square piece of cartilage from the auricle then the flaps sutured .The site of the operation in the rabbits of the treated group were irradiated with He –Ne laser 5mw power for seven days began after the operation directly. 3 rabbits from each group used for collection of specimens for histopathological examination at the 1, 2, 4 & 6 weeks post the operation. Significant

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Publication Date
Wed Jun 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
comparison Bennett's inequality and regression in determining the optimum sample size for estimating the Net Reclassification Index (NRI) using simulation
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 Researchers have increased interest in recent years in determining the optimum sample size to obtain sufficient accuracy and estimation and to obtain high-precision parameters in order to evaluate a large number of tests in the field of diagnosis at the same time. In this research, two methods were used to determine the optimum sample size to estimate the parameters of high-dimensional data. These methods are the Bennett inequality method and the regression method. The nonlinear logistic regression model is estimated by the size of each sampling method in high-dimensional data using artificial intelligence, which is the method of artificial neural network (ANN) as it gives a high-precision estimate commensurate with the dat

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Publication Date
Tue Aug 23 2022
Journal Name
International Journal Of Health Sciences
Role of activin a hormone, betacellulin (BTC) growth factor, and Heparin binding epidermal growth factor on mice embryonic development after oral administration of glycyrrhiza glabra
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Glycyrrhiza glabra is a herbal plant used for treatment of many infertility diseases. Its roots, a common herbal source, are described to soothe fetuses in pregnant mice, but there isn't enough research to know if it's safe to take during pregnancy and its effects on implantation factors. This study examines the impact of the growth factors betacellulin (BTC), heparin-binding epidermal growth factor, and activin A hormone on embryonic development after oral administration of Glycyrrhiza glabra aqueous extract to mice. In line with clinical use, an aqueous extract of Glycyrrhiza glabra roots was prepared. Pregnant mice were randomly assigned to one of four groups: Two mice groups 8 and 28 weeks old treated with water as a negative co

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Publication Date
Fri Dec 30 2011
Journal Name
Al-kindy College Medical Journal
The Role of the Use of Low Molecular Weight Heparin in the Prevention of Deep Venous Thrombosis after Total Knee Arthroplasty
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Background A prospective clinical study was
performed to compare the efficacy of the use of lowmolecular-
weight heparin group (enoxparin group)
with control group in the prevention of deep-vein
thrombosis after total knee arthroplasty.
Aim of the study: to assess the prevalence of DVT
after total knee arthroplasty and evaluate the
importance of the use of low molecular weight
heparin in the prevention of this DVT.
Methods Thirty-three patients undergoing total
knee arthroplasty were randomly divided into two
groups. One group consisted of 12 patients who
received no prophylaxis with an anticoagulant (the
control group), other group consisted of 21 patients
who received the low-molecular-weight h

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