The effect of fluvoxamine on the pharmacokinetics, safety, and tolerability of ramosetron in healthy subjects

被引:6
|
作者
Kadokura, Takeshi [1 ]
den Adel, Martin [2 ]
Krauwinkel, Walter J. J. [2 ]
Takeshige, Tetsuo [3 ]
Nishida, Akito [4 ]
机构
[1] Astellas Pharma Inc, Clin Pharmacol, Itabashi Ku, Tokyo 1748612, Japan
[2] Astellas Pharma Europe BV, Exploratory Dev, NL-2350 AC Leiderdorp, Netherlands
[3] Astellas Pharma Inc, Drug Metab Res Labs, Yodogawa Ku, Osaka 5328514, Japan
[4] Astellas Pharma Inc, Project Management, Itabashi Ku, Tokyo 1748612, Japan
关键词
CYP1A2; drug interaction; fluvoxamine; pharmacokinetics; ramosetron;
D O I
10.1007/s00228-008-0466-x
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Objective To investigate the effects of multiple doses of fluvoxamine on the pharmacokinetics, safety, and tolerability of a single oral 10-mu g dose of ramosetron. Methods This was a single-center, open, one-sequence cross-over study. On Day 1, healthy male and female subjects were administered a single dose of 10 mu g ramosetron. Dosing of fluvoxamine started with an initial morning dose of 50 mg on Day 3, followed by a twice daily (12-h interval) dosing of 50 mg on Days 4-12. The morning dose on Day 11 was administered in combination with a single dose of 10 mu g ramosetron. Results Co-administration of fluvoxamine with ramosetron resulted in an increase in the C(max) and AUC(0-inf) of ramosetron by 1.42-fold (90% CI 1.35-1.49) and 2.78-fold (90% CI 2.53-3.05), respectively. Conclusion Co-administration of the CYP1A2 inhibitor fluvoxamine with ramosetron resulted in an interaction. However, the safety data collected during the study do not indicate that this interaction will cause any major safety concerns.
引用
收藏
页码:691 / 695
页数:5
相关论文
共 50 条
  • [41] Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Benfotiamine in Healthy Subjects
    Sheng, Lei
    Cao, Wei
    Lin, Pingping
    Chen, Weili
    Xu, Hongrong
    Zhong, Chunjiu
    Yuan, Fei
    Chen, Hanjing
    Li, Hui
    Liu, Chao
    Yang, Mengjie
    Li, Xuening
    DRUG DESIGN DEVELOPMENT AND THERAPY, 2021, 15 : 1101 - 1110
  • [42] Pharmacokinetics, Safety and Tolerability of Rotigotine Transdermal Patch in Healthy Japanese and Caucasian Subjects
    Willi Cawello
    Seong R. Kim
    Marina Braun
    Jan-Peer Elshoff
    Junji Ikeda
    Tomoo Funaki
    Clinical Drug Investigation, 2014, 34 : 95 - 105
  • [43] Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects
    Li, Cuiyun
    Li, Xiaojiao
    Zhu, Xiaoxue
    Zhang, Hong
    Shen, Gong
    Kersey, Kathryn
    Ding, Yanhua
    CLINICAL THERAPEUTICS, 2020, 42 (03) : 448 - 457
  • [44] Pharmacokinetics, Pharmacodynamics, Pharmacogenomics, Safety, and Tolerability of Avatrombopag in Healthy Japanese and White Subjects
    Nomoto, Maiko
    Pastino, Gina
    Rege, Bhaskar
    Aluri, Jagadeesh
    Ferry, Jim
    Han, David
    CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2018, 7 (02): : 188 - 195
  • [45] Entecavir pharmacokinetics, safety, and tolerability after multiple ascending doses in healthy subjects
    Yan, Jing-He
    Bifano, Marc
    Olsen, Steven
    Smith, Robert A.
    Zhang, Duxi
    Grasela, Dennis M.
    LaCreta, Frank
    JOURNAL OF CLINICAL PHARMACOLOGY, 2006, 46 (11): : 1250 - 1258
  • [46] Pharmacokinetics, Pharmacodynamics, Tolerability and Safety of Single Doses of Bivalirudin in Healthy Chinese Subjects
    Zhang, Dongmei
    Wang, Zining
    Zhao, Xia
    Lu, Wei
    Gu, Jingkai
    Cui, Yimin
    BIOLOGICAL & PHARMACEUTICAL BULLETIN, 2011, 34 (12) : 1841 - 1848
  • [47] Safety, tolerability, and pharmacokinetics of raltegravir after single and multiple doses in healthy subjects
    Iwamoto, M.
    Wenning, L. A.
    Petry, A. S.
    Laethem, M.
    De Smet, M.
    Kost, J. T.
    Merschman, S. A.
    Strohmaier, K. M.
    Ramael, S.
    Lasseter, K. C.
    Stone, J. A.
    Gottesdiener, K. M.
    Wagner, J. A.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2008, 83 (02) : 293 - 299
  • [48] Evaluation of safety, tolerability, pharmacokinetics, and food effect of Danirixin oral tablets in Japanese elderly healthy subjects
    Matsuzawa, Yuki
    Ogura, Hirofumi
    Nagakubo, Takashi
    Wakamatsu, Akira
    Ambery, Claire
    Miller, Bruce
    Numachi, Yotaro
    EUROPEAN RESPIRATORY JOURNAL, 2018, 52
  • [49] Pharmacokinetics, Safety, and Tolerability of Intravenous Durlobactam and Sulbactam in Subjects with Renal Impairment and Healthy Matched Control Subjects
    O'Donnell, John
    Preston, Richard A.
    Mamikonyan, Grigor
    Stone, Emily
    Isaacs, Robin
    ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2019, 63 (09)
  • [50] Safety, Tolerability, and Pharmacokinetics of Recombinant Human Neuregulin-1 in Healthy Chinese Subjects
    Xu, Junyu
    Sun, Peihong
    Zhao, Xia
    Meng, Lei
    Wang, Xiaorui
    Qin, Xiaoyan
    Zhou, Ying
    Zhou, Mingdong
    Cui, Yimin
    AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, 2023, 23 (04) : 419 - 428