scholarly journals Single‐dose pharmacokinetics, safety, and tolerability of modified‐release formulations of lersivirine in healthy subjects

2014 ◽  
Vol 3 (6) ◽  
pp. 472-476
Author(s):  
Manoli Vourvahis ◽  
Ronnie Wang ◽  
Laure Mendes da Costa ◽  
Cunshan Wang ◽  
Barry Weatherley ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Modified Release

scholarly journals Single Ascending Dose Study to Assess Pharmacokinetic Linearity, Safety, and Tolerability of Trimetazidine - Modified Release in Healthy Human Subjects

Drug Research ◽  
2020 ◽  
Vol 70 (10) ◽  
pp. 472-477
Author(s):  
Thomas Körnicke ◽  
Deepa Arora ◽  
Abdus Samad ◽  
Sigal Kaplan ◽  
Mónika Domahidy ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Renal Elimination ◽  
Modified Release ◽  
Open Label ◽  
Healthy Human ◽  
Dose Study ◽  
Proportional Increase ◽  
Single Ascending Dose Study ◽  
Dose Proportional

Abstract Aim This study assessed the linearity of pharmacokinetics (PK) of trimetazidine (TMZ) modified-release tablets (indicated in adults as an add-on therapy for stable angina pectoris) and measured its renal elimination, safety, and tolerability in healthy subjects. Methods This was a randomized, open-label, single-ascending dose study in healthy subjects. Subjects were administered with a single dose of 35, 70, or 105 mg TMZ-modified release tablets (six subjects each). Pharmacokinetic evaluations and safety analysis were performed before the first dose and till 48 h post-first dose. Results Following administration of 35, 70, and 105 mg TMZ-modified release; the Cmax (mean±SD) was 79.32 (±23.08), 153.17 (±23.08), and 199.67 (±23.08) ng/mL, the Tmax was 5.42 (±0.49), 4.51 (±1.27), and 4.57 (±0.96) h, t1/2 was 7.75 (±1.62), 6.40 (±1.23), and 6.50 (±1.18) h, AUC(0-inf) was 1116.89 (±378.35), 1838.39 (±284.50), and 2504.84 (±348.35) ng.h/mL, CLR was 13.70 (±2.24), 14.80 (±5.91), and 19.58 (±6.24) L·h−1 and CL/F was 33.69 (±8.51), 38.85 (±6.15), and 42.74 (±7.10) L·h−1, respectively. Slope estimates for AUC(0-inf), AUC(0-t), and Cmax were less than 1. Corresponding 95% CI of the slope for the AUC parameters excluded 1, indicating that the deviation from dose-proportionality was statistically significant. Corresponding 95% CI of the slope for Cmax included 1, indicating that the less than dose-proportional increase in Cmax was not statistically significant. No significant adverse events were observed. Conclusion Substantial deviation from a dose-proportional increase in AUC(0-inf) and AUC(0-t) suggested a non-linear PK for TMZ-modified release. Single dose of TMZ-modified release was well tolerated and safe.

scholarly journals Single-dose pharmacokinetics and tolerability of pegylated interferon-α2b in young and elderly healthy subjects

2003 ◽  
Vol 56 (1) ◽  
pp. 131-134 ◽  
Author(s):  
Samir K. Gupta ◽  
Paul Glue ◽  
Sheila Jacobs ◽  
Donna Belle ◽  
Melton Affrime
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Pegylated Interferon ◽  
Interferon Α2b

Effect of Moricizine on the Pharmacokinetics of Single-Dose Theophylline in Healthy Subjects

1993 ◽  
Vol 15 (3) ◽  
pp. 199-203 ◽  
Author(s):  
Henry J. Pieniaszek ◽  
Anna F. Davidson ◽  
Irma H. Benedek
Keyword(s):  
Single Dose ◽  
Healthy Subjects

A Single-Dose, Two-Way Crossover, Bioequivalence Study of Dexmethylphenidate HCl with and without Food in Healthy Subjects

2004 ◽  
Vol 44 (2) ◽  
pp. 173-178 ◽  
Author(s):  
Steve K. Teo ◽  
Michael R. Scheffler ◽  
Anfan Wu ◽  
David I. Stirling ◽  
Steve D. Thomas ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Bioequivalence Study

Single-Dose Comparative Pharmacokinetics of Two Formulations of Lenalidomide 25 mg in Healthy Subjects: A Randomized Crossover Study

2018 ◽  
Vol 35 (2) ◽  
pp. 210-217
Author(s):  
SeungHwan Lee ◽  
Jun Gi Hwang ◽  
Sang Yeob Park ◽  
Hye Jung Lim ◽  
Sa-Won Lee ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Subjects ◽  
Randomized Crossover Study
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