scholarly journals Bioavailability study of Enoxaparin Sodium Chemi (80 mg/0.8 mL) and Clexane (80 mg/0.8 mL) subcutaneous injection in healthy adults

2021 ◽  
Author(s):  
Salvatore Febbraro ◽  
Javier Leal Martínez-Bujanda ◽  
Concepción Nieto Magro ◽  
Paolo Bettica
Keyword(s):  
Enoxaparin Sodium ◽  
Subcutaneous Injection ◽  
Healthy Adults ◽  
Bioavailability Study

scholarly journals Effects of Food and Omeprazole on a Novel Formulation of Super Bioavailability Itraconazole in Healthy Subjects

2018 ◽  
Vol 62 (12) ◽  
Author(s):  
Julian Lindsay ◽  
Stuart Mudge ◽  
George R. Thompson
Keyword(s):  
Steady State ◽  
Maximum Concentration ◽  
Healthy Adults ◽  
Plasma Exposure ◽  
Open Label ◽  
Time Curve ◽  
Dosing Interval ◽  
Fasted State ◽  
Concentration Time ◽  
Bioavailability Study

ABSTRACT To address the limited bioavailability and intolerance of the conventional itraconazole (ITZ) formulations, a new formulation labeled super bioavailability (SUBA) itraconazole has been developed; however, the specific effects of food and gastric pH are unknown. This study evaluated the pharmacokinetic profile of SUBA itraconazole under fasting and fed conditions, as well as with the concomitant administration of a proton pump inhibitor. First, the effect of food was assessed in an open-label, randomized, crossover bioavailability study of 65-mg SUBA itraconazole capsules (2 65-mg capsules twice a day) in healthy adults (n = 20) under fasting and fed conditions to steady-state levels. Second, an open-label, two-treatment, fixed-sequence comparative bioavailability study in healthy adults (n = 28) under fasted conditions compared the pharmacokinetics of a single oral dose of SUBA itraconazole capsules (2 65-mg capsules/day) with and without coadministration of daily omeprazole delayed-release capsules (1 40-mg capsule/day) under steady-state conditions. In the fed and fasted states, SUBA itraconazole demonstrated similar concentrations at the end of the dosing interval, with modestly lower total and peak ITZ exposure being shown when it was administered under fed conditions than when it was administered in the fasted state, with fed state/fasted state ratios of 78.09% (90% confidence interval [CI], 74.49 to 81.86%) for the area under the concentration-time curve over the dosing interval (14,183.2 versus 18,479.8 ng · h/ml), 73.05% (90% CI, 69.01 to 77.33%) for the maximum concentration at steady state (1,519.1 versus 2,085.2 ng/ml), and 91.53% (90% CI, 86.41 to 96.96%) for the trough concentration (1,071.5 versus 1,218.5 ng/ml) being found. When dosed concomitantly with omeprazole, there was a 22% increase in the total plasma exposure of ITZ, as measured by the area under the concentration-time curve from time zero to infinity (P = 0.0069), and a 31% increase in the peak plasma exposure of ITZ, as measured by the maximum concentration (P = 0.0083).

scholarly journals Incidence and Extent of Bruising After Subcutaneous Injection of Enoxaparin Sodium in Patients Hospitalized at Coronary Care Units

2019 ◽  
pp. 90-96
Author(s):  
Zeynab Poursafar ◽  
Shirin Jafroudi ◽  
Mojgan Baghaei ◽  
Ehsan Kazemnezhad Leyli ◽  
Maryam Zarrizei
Keyword(s):  
Enoxaparin Sodium ◽  
Subcutaneous Injection ◽  
Coronary Care ◽  
Coronary Care Units

scholarly journals Relative and Absolute Bioavailability Study of Emicizumab to Bridge Drug Products and Subcutaneous Injection Sites in Healthy Volunteers

2018 ◽  
Vol 8 (6) ◽  
pp. 702-712 ◽  
Author(s):  
Naoki Kotani ◽  
Koichiro Yoneyama ◽  
Nobuhiko Kawakami ◽  
Tohru Shimuta ◽  
Hiroyuki Fukase ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Subcutaneous Injection ◽  
Absolute Bioavailability ◽  
Drug Products ◽  
Bioavailability Study
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