scholarly journals Absence of effect of steady state bempedoic acid on cardiac repolarization: Results of a thorough QT/QTc study in healthy volunteers

2021 ◽  
Author(s):  
Benny M. Amore ◽  
Clay T. Cramer ◽  
Diane E. MacDougall ◽  
William J. Sasiela ◽  
Maurice G. Emery
Keyword(s):  
Steady State ◽  
Healthy Volunteers ◽  
Cardiac Repolarization

scholarly journals Study of cardiac repolarization in healthy volunteers performed with mizolastine, a new H 1 ‐receptor antagonist

1999 ◽  
Vol 47 (5) ◽  
pp. 515-520 ◽  
Author(s):  
Chaufour ◽  
Caplain ◽  
Lilienthal ◽  
L’Héritier ◽  
Deschamps ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Receptor Antagonist ◽  
Cardiac Repolarization

scholarly journals Pharmacokinetic Interactions of Maraviroc with Darunavir-Ritonavir, Etravirine, and Etravirine-Darunavir-Ritonavir in Healthy Volunteers: Results of Two Drug Interaction Trials

2011 ◽  
Vol 55 (5) ◽  
pp. 2290-2296 ◽  
Author(s):  
Thomas N. Kakuda ◽  
Samantha Abel ◽  
John Davis ◽  
Julia Hamlin ◽  
Monika Schöller-Gyüre ◽  
...  
Keyword(s):  
Steady State ◽  
Healthy Volunteers ◽  
Potent Inhibitor ◽  
Cytochrome P450 3A ◽  
Short Term ◽  
Two Phase ◽  
Time Curve ◽  
Safety Issues ◽  
Concentration Time ◽  
Crossover Studies

ABSTRACTThe effects of darunavir-ritonavir at 600 and 100 mg twice daily (b.i.d.) alone, 200 mg of etravirine b.i.d. alone, or 600 and 100 mg of darunavir-ritonavir b.i.d. with 200 mg etravirine b.i.d. at steady state on the steady-state pharmacokinetics of maraviroc, and vice versa, in healthy volunteers were investigated in two phase I, randomized, two-period crossover studies. Safety and tolerability were also assessed. Coadministration of 150 mg maraviroc b.i.d. with darunavir-ritonavir increased the area under the plasma concentration-time curve from 0 to 12 h (AUC12) for maraviroc 4.05-fold relative to 150 mg of maraviroc b.i.d. alone. Coadministration of 300 mg maraviroc b.i.d. with etravirine decreased the maraviroc AUC12by 53% relative to 300 mg maraviroc b.i.d. alone. Coadministration of 150 mg maraviroc b.i.d. with etravirine-darunavir-ritonavir increased the maraviroc AUC123.10-fold relative to 150 mg maraviroc b.i.d. alone. Maraviroc did not significantly affect the pharmacokinetics of etravirine, darunavir, or ritonavir. Short-term coadministration of maraviroc with darunavir-ritonavir, etravirine, or both was generally well tolerated, with no safety issues reported in either trial. Maraviroc can be coadministered with darunavir-ritonavir, etravirine, or etravirine-darunavir-ritonavir. Maraviroc should be dosed at 600 mg b.i.d. with etravirine in the absence of a potent inhibitor of cytochrome P450 3A (CYP3A) (i.e., a boosted protease inhibitor) or at 150 mg b.i.d. when coadministered with darunavir-ritonavir with or without etravirine.

scholarly journals Clinical Pharmacokinetics of Fosfomycin after Continuous Infusion Compared with Intermittent Infusion: a Randomized Crossover Study in Healthy Volunteers

2020 ◽  
Vol 65 (1) ◽  
pp. e01375-20
Author(s):  
Valentin al Jalali ◽  
Peter Matzneller ◽  
Beatrix Wulkersdorfer ◽  
Scharon Chou ◽  
Soma Bahmany ◽  
...  
Keyword(s):  
Steady State ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Continuous Infusion ◽  
Intermittent Infusion ◽  
Time Curve ◽  
Clinical Pharmacokinetics ◽  
Clinical Scenarios ◽  
Ringer’S Lactate ◽  
State Concentration

ABSTRACTContinuous infusion (CON) of fosfomycin has been proposed as potentially advantageous in certain clinical scenarios. However, no clinical data on the pharmacokinetics (PK) of fosfomycin after CON are available to date. This study aimed to investigate the PK of fosfomycin after CON and compare it with intermittent infusion (INT) of fosfomycin. A randomized two-way crossover study including 8 healthy male volunteers was performed. Each subject received fosfomycin as INT of 8 g over 30 min every 8 h and, separated by a washout period, as CON of 1 g/h preceded by a loading dose of 8 g over 30 min. PK sampling was performed for 18 and 24 h in the CON and INT groups, respectively. Fosfomycin was generally well tolerated. However, 2 out of 8 subjects (25%) developed thrombophlebitis at the infusion site following CON, which was prevented in the following subjects with a simultaneous coinfusion of Ringer’s lactate. The steady-state maximum concentration of drug in serum (Cmax) and area under the concentration-time curve from 0 to 24 h at steady state (AUCSS,0–24) of fosfomycin after INT were 551.5 ± 67.8 mg/liter and 3,678.5 ± 601.9 h · mg/liter, respectively. CON led to an average steady-state concentration of 183.8 ± 35.9 mg/liter, resulting in a calculated AUCSS,0–24 of 4,411.2 ± 862.4 h · mg/liter, which was 1.2-fold higher than that with INT. CON resulted in a 100% T>MIC (time during which the drug concentration exceeds the MIC) for MICs of ≤128 mg/liter, whereas the %T>MIC for INT was only 44% for an MIC of 128 mg/liter. CON of fosfomycin led to improved PK and PK/pharmacodynamic (PD) determinants in plasma of healthy volunteers. The clinical relevance of these findings remains to be investigated in patients.

Generic Substitution and Bioequivalence of Sodium Valproate at Steady-State in Healthy Volunteers

2008 ◽  
Vol 25 (3) ◽  
pp. 183-195
Author(s):  
Tanvir K. Gill ◽  
Ashish R. Agrawal ◽  
Muzaffar Iqbal ◽  
Tausif Monif ◽  
P.L. Sharma
Keyword(s):  
Steady State ◽  
Healthy Volunteers ◽  
Sodium Valproate ◽  
Generic Substitution

Steady-State Pharmacokinetics and Tolerability of Modafinil Given Alone or in Combination with Methylphenidate in Healthy Volunteers

2001 ◽  
Vol 41 (8) ◽  
pp. 895-904 ◽  
Author(s):  
Edward T. Hellriegel ◽  
Sanjay Arora ◽  
Michael Nelson ◽  
Philmore Robertson
Keyword(s):  
Steady State ◽  
Healthy Volunteers

Steady-State Pharmacokinetics and Tolerability of Modafinil Administered Alone or in Combination with Dextroamphetamine in Healthy Volunteers

2002 ◽  
Vol 42 (4) ◽  
pp. 450-460 ◽  
Author(s):  
Edward T. Hellriegel ◽  
Sanjay Arora ◽  
Michael Nelson ◽  
Philmore Robertson
Keyword(s):  
Steady State ◽  
Healthy Volunteers
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