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Bioequivalence and Pharmacokinetics of Two Formulations of Amlodipine Tablets in Healthy Subjects
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The bioequivalence of a single dose tablet containing 5 mg amlodipine as a test product in comparison to Norvasc® 5 mg tablet (Pfizer USA) as the reference product was studied. Both products were administered to twenty eight healthy male adult subjects applying  a fasting, single-dose, two-treatment, two-period, two-sequence, randomized crossover design with two weeks washout period between dosing. Twenty blood samples were withdrawn from each subject over 144 hours period. Amlodipine concentrations were determined in plasma by a validated HPLC-MS/MS method. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax, Tmax, AUC0-t, AUC0-Â¥, Cmax/AUC0-Â¥, lZ, T0.5, MRT, Cl/F and Vd/F; were calculated applying non-compartmental analysis. The average values of the above parameters  for the test formula were 1.99 ng/ml, 8.3 hours, 82.87 ng.hr/ml, 95.23 ng.hr/ml, 0.0219 hr-1, 0.018 hr-1, 38.5 hr, 56.2 hr, 60.9 l/hr and 3483 liters, respectively. The average values of these parameter for the reference formula were 1.92 ng/ml, 7.9 hours, 76.3 ng.hr/ml, 89.31 ng.hr/ml, 0.0225hr-1, 0.019  hr-1, 36.7 hr, 59.9 hr, 69.5 l/hr, and 3983.4 liters, respectively. The pharmacokinetic parameters mentioned above were statistically analyzed by ANOVA test. Ln-transformed values of the pharmacokinetic parameters used for bioequivalence testing; Cmax, AUC0-t and AUC0-Â¥ ; were also statistically analyzed by ANOVA, 90% Confidence Interval (CI) and Schuirmann’s two one-sided t-tests. For the Tmax, parametric and nonparametric tests were applied. Based on FDA criteria on bioequivalence, the results of the above statistical tests demonstrated bioequivalence of the two products.

Keywords: Amlodipine, Pharmacokinetic, Bioequivalence , HPLC/MS/MS.

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Publication Date
Thu Nov 01 2018
Journal Name
Iraqi Journal Of Community Medicine
Leg alopecia in Patients with Coronary Heart Diseases in comparison with Healthy Control in Adult Males.
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KE Sharquie, JR Al-Rawi, AA Noaimi, RA Al-Khammasi, Iraqi Journal of Community Medicine, 2018

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Publication Date
Wed Dec 13 2023
Journal Name
Drug And Chemical Toxicology
Single and repeat-dose toxicity and local tolerance assessment of newly developed oil emulsion adjuvant formulations for veterinary purposes
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Publication Date
Wed May 12 2021
Journal Name
Indian Journal Of Forensic Medicine & Toxicology
The Relationship of Healthy Rationalist Pundit Thinking to the Spiking and Block Performance of Volleyball For Junior Players
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Publication Date
Sun Mar 08 2026
Journal Name
Statistics, Optimization And Information Computing
Adult Dengue Fever in Bangladesh: A One-Sample Rank-Based Test of Hematologic Location Against Healthy References
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Dengue fever is a mosquito-borne viral infection that produces characteristic abnormalities in routine blood tests, yet these hematologic changes are typically analysed separately for each parameter rather than as a combined multivariate profile. This study investigated whether the joint hematologic profile of adult dengue patients in Bangladesh is systematically displaced from healthy adult reference values. We analysed a cohort of laboratory-confirmed adult dengue cases from a Bangladeshi hospital and focused on four core hematologic indices: haemoglobin, white blood cell count, platelet count, and platelet distribution width (PDW). External adult reference means were used to define a healthy location vector, and robust multivariate infer

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Publication Date
Fri Jun 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
Handling a problem of transport solid waste in Baghdad City to Healthy landfill sites using transportation Model
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 A problem of solid waste became in the present day common global problem among all countries, whether developing or developed countries, and can say that no country in the world today is immuning from this dilemma which must find appropriate solutions. The problem has reached a stage that can not ignore or delay, but has became a daily problem occupies the minds of ecologists, economists and politicians took occupies center front in the lists of  priorities for the countries in terms of finding solutions to the rapid scientific and radical them. and that transport costs constitute an important component of total costs borne by the municipal districts in the process of disposal of solid waste, so any improvement in the

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Publication Date
Sun Jun 30 2013
Journal Name
Al-kindy College Medical Journal
Serodiffusion of Helicobacter Pylori and HAV in Patients Attending Two Centers in Baghdad
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Background: Helicobacters are motile curved, oxidase and catalase positive,
gram negative rods similar in morphology to vibrios. The cells have polar flagella
and are often attached at their ends given pairs "S" shapes or seagull
appearance.
Object i ves: The present study was undertaken to estimate the serodiffusion of
H. pylori and hepatitis A virus (HAV) in 300 patients attending two centers in
Baghdad.
Metthods:: HAV was determined by the detection of HAV-IgM in the serum samples. Detection of H. pylori was by ELISA and endoscopic examination.
Resul t s: The serodiffusion of H. pylori was 40% (n=120). Out of the 120
patients infected with H. pylori, 50(41 .6%) patients were diagnosed clinically to
have g

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Publication Date
Thu Jun 30 2016
Journal Name
Al-kindy College Medical Journal
Correlation of blood, salivary glucose levels and bloo HbA1c% in healthy and previously diagnosed Diabetes Mellitus Type 2 in a sec ion of patients of Baghdad hospital, Iraq
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Background: Diabetes mellitus is a metabolic disorder affecting people worldwide, which require constant monitoring of their glucose levels. Commonly employed procedures include collection of blood or urine samples causing discomfort to the patients. Necessity arises to find alternative non invasive technique is required to monitor glucose levels. Saliva is one of most abundant secretions in the human body and its collection is easy, noninvasive and painless technique. Objective: The aim of this study was to determine the efficacy of saliva as a diagnostic tool by study the correlation between blood and salivary glucose levels and glycosylated hemoglobin (HbA1c%) in diabetes and non diabetes, and the comparison of salivary glucose level

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Publication Date
Fri Sep 04 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Cephalometric Study of Iraqi Adult Subjects with Cl I and Cl III Skeletal Relationships and Their Effects on Masseter Muscle Thickness by Using Ultrasonography
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Background: Masseter muscle is one of the most obvious muscles of mastication and considered as one indicator of jaw muscle activity. It has a major influence on the transverse growth of the midface and the vertical growth of the mandible. This study undertaken to determine the role of cephalometric analysis for discrimination between Cl I and Cl III skeletal relationships, determine the role of ultrasonography in determination of masseter muscle thickness, compare masseter muscle thickness between Cl I and Cl III skeletal relationships, and determine the effect of gender on masseter muscle thickness. Material and Method: The sample of the current study consisted of 70 Iraqi subjects 40 males and 30 females with age ranging 18-25 years. The

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Publication Date
Fri Jan 01 2021
Journal Name
Microchemical Journal
A flow analysis system integrating an optoelectronic detector for the quantitative determination of active ingredients in pharmaceutical formulations
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Publication Date
Fri Jan 01 2021
Journal Name
Microchemical Journal
A flow analysis system integrating an optoelectronic detector for the quantitative determination of active ingredients in pharmaceutical formulations
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Scopus (24)
Crossref (17)
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