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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
In Vivo Toxicity Study of Nerium oleander's Leaves and Flowers Aqueous Extracts in Mice (Cytogenetic, Biochemical and Hematological Study)
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The present research was carried out to assess the toxic effect of oral administration of the aqueous extract of Nerium oleander leaves and flowers daily at doses of (25) mg/kg body weight for four weeks in mice. The toxicity of this plant parts was determined after two and four weeks by measuring the parameters of cytogenetic (mitotic index, micronucleus %), and serum levels of the hematological (RBC, Hb, WBC) and biochemical (GOT, GPT, ALT, AST) indexes in comparison with that of the control (normal saline), also clinical signs were determined. The results showed a significant decrease in mitotic index while an obvious raise was seen in micronucleus percentage in comparison with that of the control after the two periods of admini

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Publication Date
Thu Jun 30 2022
Journal Name
Gsc Biological And Pharmaceutical Sciences
Revision of public health and clinical importance of amoebiasis in Iraq
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Amebiasis, related to the pathogenic parasite Entamoeba histolytica, is a prominent cause of diarrhea globally. Amebiasis is primarily a disease of impoverished communities in developing nations, although it has recently arisen as a significant infection among returning tourists and immigrants. Severe cases are linked to a high case fatality rate. Although polymerase chain reaction (PCR)-based diagnosis is becoming more widely available, it is still underutilized. Treatment with nitroimidazoles is now suggested, however novel parasite medication research is a top priority. To avoid problems, amebiasis should be considered before corticosteroid therapy. Because there is no effective vaccination, sanitation and availability to clean w

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Publication Date
Tue Aug 05 2014
Journal Name
International Journal Of Pharmacy And Pharmaceutical Sciences
FORMULATION AND EVALUATION OF FLOATING ORAL IN-SITU GEL OF METRONIDAZOLE
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Publication Date
Sun Mar 02 2008
Journal Name
Baghdad Science Journal
Colonization of Staphylococcus xylosus in the kidneys and bladder of mice
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Two isolates of Staphylococcus xylosus (urease producer and non urease producer) were injected in mice at a dose of 2 × 108 colony-forming units (CFU) intraurethrally. Results showed that both isolates were able to colonize kidney and bladder of the injected mice, regardless of their urease production. Moreover, there were insignificant differences between the two groups. These results emphasized the pathogenicity of this bacteria in UTI.

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Publication Date
Fri Mar 23 2018
Journal Name
Scientific Conference
Philosophy of Abstraction and Construction of Space in Contemporary Iraqi Theater
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Philosophy of Abstraction and Construction of Space in Contemporary Iraqi Theater Abstract The aesthetic and stylistic features in the theatrical play develop according to the changes of the age and its developments. Stylistic forms different from the prevailing and familiar in the visions of contemporary theatre directors emerged which adopt the removal of traditional awareness in the creation of the visual space of theatrical discourse, through adopting contemporary formats and structures which depend on the abstraction representations in the aesthetic construction of the contemporary theatre show which is one of the prerequisites of the postmodern theater, that produces aesthetic data based on abstract metaphors in the formation of th

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Publication Date
Sun Sep 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
The reality of Taxation in Iraq and Aspect of it’s Development
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This research is considered a simple attempt and effort which is it first and last target is to point at the procedures of the taxes account that aims to reduce the taxes from the persons and give free to the person who estimates the tax to practice what comes from the competent authorities to describe the person who estimates the tax and not an accountant who practice the accountant procedures which are imposed on him by the annual terms from higher administrations , So he can not evaluate   state of the person who pay the tax , and he might be dissatisfied with his job , because his role can’t  be activated from the general foundation taxes.

And so , this research includes four fields:-

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Publication Date
Thu Feb 07 2019
Journal Name
Journal Of The College Of Education For Women
(Love and Love) in the light of the significance of Quranic
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Thanks allah and peace be upon our prophet muhammed and upon his family and his
followers……
Love means in holy quran what comes to people s mind nowadays and what it inspired its
signi ficence is related with sensual desire and it means adore and passion .by the waythe
word (ishiq) adore wasn’t mentioned in holy quran which means that both of their bases are
farfrom each oiter in m eaning.
The significance of love means virtue while adore means the excess and desire so adore is
dis praised . as al askari said (died 395h )between love and adore.adore is the strain of desire
to get the purpose from lovers if it was ahuman who intended to make love affairs.
Today both of love and adore changed in their meani

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Publication Date
Thu Mar 30 2023
Journal Name
College Of Islamic Sciences
Description of nature and the joys of life in Fatimid poetry
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This research deals with the aesthetics of describing nature and the joys of urban life in the environment of Fatimid Egypt, among a group of poets, who were deceived by its enchanting beauty and breathtaking scenery, through it they depicted the reality of the life they live, and the things that involved them, as well as showing their personal culture, and the joys of life that experience, articulating this with a descriptive and analytical study, focusing on how the poet portrayed the visual scene, in an important stage of Arabic literature in Egypt.

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Publication Date
Wed Jan 28 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Incidence of Hodgkin's lymphoma of head and neck in Baghdad city
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Background: Hodgkin's lymphoma (HL), formerly called Hodgkin's diseases is an uncommon form of lymphoma. The incidence of Hodgkin's lymphoma shows marked heterogeneity with respect to age, gender, race, geographic area, social class and histological subtype. This study was carried out in an attempt to evaluate the incidence of Hodgkin's lymphoma of head and neck in Baghdad city. Materials and Methods: The diagnosed cases of Hodgkin's lymphoma of head and neck region in Baghdad city between (1990-1999) were collected and analyzed according to age, gender, site and the histopathological subtypes of the tumor. Results: Out of (702) cases of Hodgkin's lymphoma of ten years between (1990-1999),(362 ) of them were occurred in the head and neck

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Publication Date
Sat Jan 01 2022
Journal Name
Materials Today: Proceedings
Application of levofloxacin and doxycycline in treatment of vaginal chlamydial infection
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Doxycycline and levofloxacin are heterocyclic organic compounds that are now popularly used to treat some bacterial infections. In this study which was conducted on patients from a private clinic, we compared the use of two commonly used antibiotics for the treatment of diagnosed cases with vaginal chlamydial infection: levofloxacin and doxycycline. Vaginal chlamydial infection is considered to be a very common sexually transmitted infection. It may have minimal symptoms which can lead to neglect by the patient until it leads to some important complications among which is the inability to become pregnant. This indicates early diagnosis and treatment of this infection. By comparing the results of treatment we concluded that there is no much

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