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Bioequivalence and Pharmacokinetics of Two Formulations of Amlodipine Tablets in Healthy Subjects

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 Twenty blood samples were withdrawn from each subject over 144 hours period.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
Sun Mar 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions

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 we

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Bioequivalence of Two Formulations of Amoxicillin in Human Healthy Volunteers on (HPLC) Technique

Amoxicillin is commercially available in the form of capsules and tablets containing 250mg or 500mg for oral administration. It is also available in the form of suspension containing "25mg/ml” . Amoxicillin is presently used as the most common antibiotics .Ten healthy Human volunteers were characterized respected to their pharmacokinetic and bioavailability of two formulations of Amoxicillin from two sources of  industrial companies  after a single dose administration was given orally. A procedure is described for determination the concentration levels of Amoxicillin in human plasma of healthy volunteers using high performance liquid chromatography (HPLC) with reversed-phase isocratic column at low wave length of UV-visib

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Publication Date
Sat Feb 18 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Effect of Food on the Pharmacokinetics of Fluoxetine in Healthy Male Adult Volunteers(Conference Paper )#

Fluoxetine (FX) is an antidepressant drug administered only orally in humans. Despite the wide use of FX, until now, there is only limited literature concerning the pharmacokinetics (PK) of FX and the effect of food on its PK. Thus, the objective of this investigation was to study the PK of FX in Arabic healthy male adult volunteers under fasting and fed conditions. In the fasting study, FX 20 mg capsules (Prozac®, Eli Lilly, Canada) were administered to 41 volunteers after overnight fasting of 12 hours, followed by blood sampling from each volunteer immediately before dosing (zero time) and then at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 60, 72, 96, 120, and eventually at 144 hours after FX dosing. The fed study was conduct

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Publication Date
Wed Oct 01 2008
Journal Name
Journal Of The Faculty Of Medicine Baghdad
Resistin , Insulin resistance and BMI in type 2 diabetes mellitus and healthy subjects.

Background : Obesity and insulin resistance have been quite well recognized as fundamental and leading causes of major health issues such as diabetes, hyperlipidemia, hypertension, and cardiovascular diseases. Abdominal obesity, particularly visceral adiposity is considered to play a major role in causing insulin resistance and type 2 diabetes mellitus , T2DM
The resistin is considered one of the causes of insulin resistance which lead to hyperinsulinemia and a decrease in the quantitative insulin sensitivity check index (Quicki)
which has been recently reported to be a useful marker of insulin resistance in patients with T2DM.
Objective : The aim of the present study is to find the relationship between

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Publication Date
Wed Oct 01 2008
Journal Name
Journal Of The Faculty Of Medicine Baghdad
Effect of aging on growth hormone-leptin axis in normal and obese healthy subjects

Background: Growth hormone is a hormone responsible for the normal body growth and development by stimulation protein production in muscle cells and
energy release for breakdown of fat. On the other hand leptin is a newly discovered hormone that is mainly synthesized in adipose tissues it decreases food intake by
causing satiety and promoting energy combustion . Both aging and obesity are associated with a reduction in growth hormone secretion. In the mean time obese
humans have increased circulating leptin.
Objective: The aim of this paper is to shed light on the contribution of these two hormones in the mechanism of aging process in an attempt of improving this
process for a better life at old ages.&n

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Publication Date
Sun Jul 04 2010
Journal Name
Journal Of The Faculty Of Medicine Baghdad
Effect of Moderate Exercise on the level of DHEAS hormone and lymphocyte apoptosis in healthy subjects.

Background: Physical exercise is essential for performance of the immune system. The integrity of immune response is dependent on the intensity and duration of the exercise performed. During exercise the metabolic and hormonal changes that occurred can induce lymphocyte apoptosis. Dehydroepiandrosteron sulphate (DHEAS) is one of the hormones that is affected by exercise, it is an androgen released from the adrenal cortex in response to adrenocortiocotropin releasing hormone (ACTH). DHEAS is regarded as an anti-aging hormone; it is primarily immune enhancing, providing some degree of counterbalance to the potentially detrimental effects of catecholamine and cortisol which are immunosuppressive if chronic

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Publication Date
Fri Sep 29 2023
Journal Name
Pakistan Journal Of Ophthalmology
Corneal Parameters Measurement in Healthy Subjects Using Scheimpflug and Anterior Segment Optical Coherence Tomography

Purpose:  To compare the central corneal thickness (CCT),minimum corneal thickness (MCT) and corneal power measured using theScheimpflug-Placido device and optical coherence tomography (OCT) in healthy eyes. Study Design:  Descriptive observational. Place and Duration of Study:  Al-Kindy college of medicine/university of Baghdad, from June 2021 to April 2022. Methods:  A total of 200 eyes of 200 individuals were enrolled in this study. CCT and MCT measurements were carried out using spectral-domain optical coherence tomography (Optovue) and a Scheimpflug-Placido topographer (Sirius).The agreement between the two approaches was assessed using Bland-Altman analysis in this study. Results:  Mean age was 28.54 ± 6.6 years, me

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Publication Date
Sat Mar 02 2019
Journal Name
World Heart Journal
The Effects of Chronic Cigarette Smoking on the Right Ventricular Functions in Healthy Young Male Subjects: A Speckle Tracking Echocardiographic Study

Background: Chronic cigarette smoking is one of the major risk factors for coronary artery disease. However, it has additional cardiac adverse effects independent of coronary atherosclerosis. Patient and Methods: After informed consent and perm- ission from the review board of the hospital, 80 healthy subjects who were classified as smokers or non-smokers were included in the study. They were examined by standard echocardiography protocol which was followed by two-dimensional speckle tracking to assess the functions of the right ventricle. Results: The tricuspid annular plane systolic excursion (TAPSE) was significantly reduced in smokers as compared to non-smokers (P < 0.05). The tricuspid flow peak late diastolic velocity (A wave) was sig

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Scopus
Publication Date
Mon May 15 2023
Journal Name
Gsc Advanced Research And Reviews
Teratoma induced by amlodipine drug in fetus rats

The current study, performed during the period from February 2021 to June 2022 at the University of Thi- Qar/ College of Education for Pure Sciences, and aimed to follow the changes in external morphological features at different Embryonic developmental stages in pregnant rats treated with different doses of amlodipine. Usage In this study, 18 pregnant rats were randomly divided into three groups, each with six pregnant rats. Each group received different concentrations of amlodipine (0.3, 0.5) in oral doses until the 20th day of gestation, while the control group was injected with 0.9% normal saline. Teratomas are bizarre tumors derived from embryonic tissue that are normally found only in the gonadal and sacral regions of adults. Primary

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Publication Date
Sun Mar 15 2020
Journal Name
Journal Of Baghdad College Of Dentistry
Oxidative stress status in hypertensive patients on amlodipine treatment

Background: Oxidative stress may contribute to the etiology of hypertension in humans. Oxidative stress is an imbalance between reactive oxygen species (ROS) and antioxidant defense mechanisms, causing damage to biological macromolecules and dysregulation of normal metabolism and physiology. Amlodipine as an antihypertensive agent is a long-acting calcium channel blocker that dilates blood vessels and improves blood flow. The aim of this study was to assess the oxidative stress in hypertensive patients on Amlodipine treatment through the assessment of salivary Malondialdehyde (MDA) and superoxide dismutase (SOD) as a marker of oxidative stress.

Mat

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