Preferred Language
Articles
/
bijps-404
Bioequivalence and Pharmacokinetics of Two Formulations of Amlodipine Tablets in Healthy Subjects
...Show More Authors

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 Twenty blood samples were withdrawn from each subject over 144 hours period.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.

Crossref
View Publication Preview PDF
Quick Preview PDF
Publication Date
Wed Apr 01 2020
Journal Name
International Journal Of Psychosocial Rehabilitation,
The Effect of Using Resistance and Medical Ozone Training on Testosterone and Some Physiological Variables in Swimmers
...Show More Authors

م.د. فاطمة حميد ،أ.م.د وفاء صباح محمد الخفاجي, International Journal of Psychosocial Rehabilitation,, 2020 - Cited by 1

View Publication
Publication Date
Tue Jan 28 2014
Journal Name
Toxins
Co-occurrence of the Cyanotoxins BMAA, DABA and Anatoxin-a in Nebraska Reservoirs, Fish, and Aquatic Plants
...Show More Authors

View Publication
Scopus (118)
Crossref (115)
Scopus Clarivate Crossref
Publication Date
Sat Mar 30 2024
Journal Name
مجلة نسق
Education Skills and Their Role in the Health and Psychological Development of the Child An Anthropological Study
...Show More Authors

The study highlighted the transformation of value systems and educational patterns between past and present, especially with the introduction of modern variables and means, such as mobile phones, the internet, social media, and others. These factors have contributed both positively and negatively to the study. The study highlights the integral role of the school in collaboration with the family in guiding and educating children. It also emphasizes the active role of the school in developing students' abilities and skills, either attracting them to school or vice versa. This includes an examination of the essential skills required in education and their role in achieving a state of psychological well-being and systematically developing child

... Show More
View Publication
Publication Date
Sun Jun 08 2025
Journal Name
Journal Of Natural Science, Biology And Medicine
The Value of White Blood Cells and Platelets Indices in Prediction of Tubal Ectopic Pregnancy Rupture
...Show More Authors

View Publication
Publication Date
Tue Jan 01 2019
Journal Name
Advances In Animal And Veterinary Sciences
Community Composition of Parasitic Nematodes of Cyprinion Macrostomum from North and Mid West Regions In Iraq
...Show More Authors

View Publication
Scopus Crossref
Publication Date
Tue Jun 13 2023
Journal Name
International Journal Of Engineering Business Management
The role of environmental management accounting information in the design process of environmental and sustainable products
...Show More Authors

The aim of this study is to investigate the effect of environmental management accounting information (EMAI) on the design process of environmental and sustainable products of Iraqi industrial companies. This process has five different sub-processes: research process, analysis process, conceptual design process, detailed design process and design production process. The study uses the quantitative approach as the questionnaire was designed and distributed to 87 quality managers, production managers, design managers and financial managers. The MANOVA analysis shows that EMAI has a positive and significant effect on three of these processes, namely research process, analysis process and detailed design process, while EMAI has an insi

... Show More
View Publication
Scopus (2)
Scopus Clarivate Crossref
Publication Date
Tue Sep 13 2022
Journal Name
Water Supply
Stable isotope composition in precipitation and groundwater of Shwan Sub-Basin, Kirkuk governorate, northeast of Iraq
...Show More Authors
Abstract<p>Stable isotope composition of δ2H and δ18O was investigated in the water resources of the Shwan sub-Basin northeast of Iraq. The study objects conceived the possible factors that affect the stable isotopes’ composition in precipitation additionally to achieve information concerning recharge processes and estimate the groundwater recharge sources. In this study, four precipitation samples were collected at the study area for the 2020–2021 hydrological year. Thirty-two groundwater samples and one surface water sample from Lesser Zab River (LZR) were collected during the same period for two sampling seasons. The results of observed meteorological data show a very small amount of pr</p> ... Show More
View Publication Preview PDF
Scopus (8)
Crossref (6)
Scopus Clarivate Crossref
Publication Date
Mon Dec 20 2021
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
NATURE OF VARIABILITY OF CANDAHARIA LEVANDERI (SIMROTH, 1902) IN THE FERGHANA AND SURKHAN - SHERABAD VALLEYS, UZBEKISTAN
...Show More Authors

The variability of Candaharia levanderi (Simroth, 1902)(Gastropoda, Stylommatophora, Parmacellidae) in two biotopes (southern and northern slopes, the Kampirtepa gorges, the Kugitang Tau ridge) has been investigated using polymerase chain reaction (PCR) with the implementation of primers, the 18S DNA of the region is amplified, the variability (sharply differing in color) of two populations of C. levanderi is studied .
The first population is in the suburbs of Namangan, (Namangan Region); the second population is in Kampirtepa gorges, Kugitang Tau ridge (Surkhandarya Region). It is established that, most often, the variability of morphological signs is observed on the coloration of mollusks. The development of body coloration is an ad

... Show More
View Publication Preview PDF
Scopus (2)
Scopus Crossref
Publication Date
Mon Feb 04 2019
Journal Name
Journal Of The College Of Education For Women
Modification of Searle’s Speech Act of Promising in its Application to Selected Religious and Political Texts
...Show More Authors

This study presents certain modifications done to the conditions set by Searle
(1969: 57) concerning the speech act of promising in order to render them to selected
sayings of Prophet Muhammad (P.B.U.H.) and Jesus Christ (P.B.U.H.) and to
political texts. These modifications make the conditions of the speech act of
promising appropriate for sincere promises made by the Messengers of God since
they deliver their Messages of God but they are unable, as Messengers, to fulfill
God’s promises which they make as part of their Messages and by representatives of
States who deliver speeches on behalf of their Governments. These are the only two
situations where the speakers can make promises and do not fulfill these prom

... Show More
View Publication Preview PDF
Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Induction of chromosomal aberrations by zinc phosphide in of illiteracy sperm cells and eggs laboratory rats
...Show More Authors

1 - is not affected by illiteracy cells painful eggs after the first and seventh of the various concentrations used but found the effect of 21 and 35 days after treatment2 - repeat chromosomal aberrations illiteracy eggs cells no different distortions occurring sperm cells During Altnavra phase3 - increased chromosomal aberrations increase the dose especially for 21 and 35 days4 - The connective tissue is more sensitive phase of the pesticide from Altnavra phase

View Publication Preview PDF