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A Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics of Fixed-Dose Grazoprevir/Elbasvir in Healthy Chinese Participants

Feb 11, 2020

Haiyan Li,1 Zhenhua Yang,1 Shuang Zhang,1 Lin Xu,1 Yudong Wei,1 Jun Jiang,2 Luzelena Caro,3 Hwa-Ping Feng,3 Jacqueline B McCrea,3 Meng Li,2 Shuang Xie,2 Jiangdian Wang,2 Xu Min Zhao,2 Shengmei Mu2 1Drug Clinical Trial Center, Peking University Third Hospital, Beijing, People’s Republic of China; 2Department of Infectious Diseases, MSD (China) R&D, Beijing, People’s Republic of China; 3Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA Correspondence: Haiyan Li Drug Clinical Trial Center, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing 100191, People’s Republic of China Tel +86 108 226 6226 Email haiyanli1027@hotmail.com Purpose: The burden of hepatitis C virus infection is particularly high in Asian countries, and new treatments are urgently needed. The purpose of this study was to characterize the pharmacokinetics (PK) and safety of the fixed-dose combination tablet of elbasvir/grazoprevir in healthy Chinese participants. Patient and Methods: In this Phase I, single-site, open-label, 3-period study in healthy Chinese adults, participants received a single tablet of elbasvir 50 mg/grazoprevir 100 mg, followed by blood sampling for up to 96 hrs ( http://www.chinadrugtrials.org.cn/ CTR20160034; Protocol PN071). Participants then received 1 tablet daily for 10 days, followed by a minimum 10-day washout, after which participants received a single dose of 2 tablets (elbasvir 100 mg/grazoprevir 200 mg). Elbasvir and grazoprevir PK were assessed following single and multiple doses. Safety and tolerability were also evaluated. Results: Twelve participants (50% male) were enrolled in and completed the study. Following single-dose oral administration of elbasvir 50 mg/grazoprevir 100 mg or elbasvir 100 mg/grazoprevir 200 mg, the median Tmax was 3– 4 hrs and elimination half-life was 18 hrs (elbasvir) and 30 hrs (grazoprevir). Multiple-dose administration resulted in AUC0– 24 accumulation ratios of 1.58 (elbasvir) and 2.35 (grazoprevir). Both elbasvir 50 mg/grazoprevir 100 mg and 100 mg/200 mg regimens were generally well tolerated. Conclusion: Single-dose administration of elbasvir 50 mg/grazoprevir 100 mg or 100 mg/200 mg and once-daily administration of elbasvir 50 mg/grazoprevir 100 mg for 10 days has been adequately characterized, with PK values within the expected range, and was generally well tolerated in healthy Chinese male and female participants. Keywords: elbasvir, grazoprevir, healthy volunteers, hepatitis C virus, pharmacokinetics This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License . By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms .

Xu Min Investments

1 Investments

Xu Min has made 1 investments. Their latest investment was in JOY STYLE as part of their Angel on September 9, 2017.

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Xu Min Investments Activity

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Date

Round

Company

Amount

New?

Co-Investors

Sources

9/16/2017

Angel

JOY STYLE

$0.76M

Yes

2

Date

9/16/2017

Round

Angel

Company

JOY STYLE

Amount

$0.76M

New?

Yes

Co-Investors

Sources

2

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