一二三四区视频,亚洲少妇熟女色,日本久热无码视频网,欧美国产日韩大尺度,亚洲a视频,久久少妇一区二区,日韩999无码视频,刺激久久久久久久,啊啊啊啊不要啊在线

ChemicalBook >> journal list >> Clinical Drug Investigation >>article
Clinical Drug Investigation

Clinical Drug Investigation

IF: 2.89
Download PDF

Safety, Tolerability, and Pharmacokinetics of the Novel Anti-influenza Agent Baloxavir Marboxil in Healthy Adults: Phase I Study Findings.

Published:1 December 2018 DOI: 10.1007/s40261-018-0710-9 PMID: 30288682
Hiroki Koshimichi, Toru Ishibashi, Nao Kawaguchi, Chisako Sato, Akira Kawasaki, Toshihiro Wajima

Abstract

Background and objective: Baloxavir marboxil, a prodrug that is metabolized to baloxavir acid, suppresses viral replication by inhibiting cap-dependent endonuclease. This first-in-human phase I study evaluated the safety, tolerability, and pharmacokinetics of baloxavir marboxil/baloxavir acid in healthy Japanese volunteers (Study 1), while food effects were evaluated in a separate phase I, crossover study in healthy Japanese volunteers (Study 2).

Methods: Study 1 participants were randomized to single-dose oral baloxavir marboxil (6, 20, 40, 60, or 80?mg; n?=?6 per dose) or placebo (n?=?10), while Study 2 participants (n?=?15) received single-dose oral baloxavir marboxil 20?mg in fasted, fed, and before-meal states.

Results: Baloxavir marboxil was well tolerated; there were few treatment-emergent adverse events and no serious adverse events/deaths. The mean plasma baloxavir acid concentration 24?h after single-dose (C24) oral baloxavir marboxil 6?mg was 6.92?ng/mL, exceeding the target C24 (6.85?ng/mL) estimated in nonclinical studies. In Study 1, baloxavir acid exposure demonstrated dose-proportional increases in the fasted state, with maximum plasma concentration generally attained within 3.5?h. Terminal elimination half-life ranged from 49 to 91?h. In Study 2, exposure was decreased and apparent clearance increased in the fed and before-meal states versus the fasted state; however, exposure exceeded the target C24 in all states.

Conclusion: Single-dose oral baloxavir marboxil was well tolerated, had a favorable safety profile, and had favorable pharmacokinetic characteristics, including a long half-life, supporting single oral dosing. The baloxavir acid area under the plasma concentration-time curve decreased with food intake by approximately 40%.

Substances (3)

Related products
Procduct Name CAS Molecular Formula Supplier Price
Baloxavir marboxil 1985606-14-1 C27H23F2N3O7S 369 suppliers Inquiry
Baloxavir 1985605-59-1 C24H19F2N3O4S 235 suppliers Inquiry
Baloxavir acid - Inquiry

Similar articles

IF:4.1

Baloxavir Marboxil: A Review in Acute Uncomplicated Influenza.

ACS Chemical Neuroscience Matt Shirley,etc Published: 1 July 2020
IF:5.4

Baloxavir Marboxil: An Original New Drug against Influenza.

ACS Applied Energy Materials Fran?ois Dufrasne,etc Published: 24 December 2021
IF:0

Single- and Multiple-Dose Pharmacokinetics of Dapoxetine Hydrochloride, a Novel Agent for the Treatment of Premature Ejaculation

The Journal of Clinical Pharmacology Nishit B. Modi PhD, Mark J. Dresser PhD,etc Published: 8 March 2013
萨迦县| 巴马| 黄陵县| 武穴市| 玉林市| 揭西县| 民丰县| 岐山县| 商丘市| 涿州市| 乌拉特后旗| 灌南县| 弥勒县| 鄂伦春自治旗| 镇坪县| 白山市| 平江县| 伊宁县| 盐城市| 蛟河市| 新乡市| 义马市| 蒙城县| 嵊州市| 樟树市| 许昌县| 建平县| 漳平市| 福建省| 大厂| 福海县| 河池市| 石狮市| 饶阳县| 德江县| 宁化县| 黄大仙区| 阳原县| 荣昌县| 荃湾区| 南漳县|