PMID- 37740607
OWN - NLM
STAT- MEDLINE
DCOM- 20240207
LR  - 20240416
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Linking)
VI  - 13
IP  - 2
DP  - 2024 Feb
TI  - Effect of a High-Fat Diet on the Pharmacokinetics and Safety of Rivaroxaban in 
      Healthy Chinese Subjects.
PG  - 146-151
LID - 10.1002/cpdd.1330 [doi]
AB  - The effects of food on the pharmacokinetics (PKs) and safety of 10-mg rivaroxaban 
      tablets in healthy Chinese subjects were investigated from 1 bioequivalence 
      trial. The bioequivalence trial was designed as randomized, open-label, 
      2-sequence, 4-period crossover under both fasted and fed conditions. A total of 
      56 healthy subjects were enrolled, 62.5% were male. These subjects received a 
      single oral 10-mg dose of rivaroxaban with a 7-day washout between 4 periods. 
      Serial PK samples were collected and plasma concentrations were analyzed using 
      validated high-performance liquid chromatography-mass spectrometry. 
      Pharmacokinetic parameters were calculated by noncompartmental methods. The BE 
      module of WinNonLin was used for statistical analysis of the maximum 
      concentration (C(max) ), the area under the concentration-time curve from zero to 
      the final measurable concentration (AUC(0-t) ), and the area under the 
      concentration-time curve from time zero to infinity (AUC(0-infinity) ) of rivaroxaban in 
      plasma. Compared with the fasted state, the C(max) , AUC(0-t) , and AUC(0-infinity) of 
      rivaroxaban significantly increased by 47%, 28%, and 26%, respectively, with oral 
      administration of rivaroxaban 10 mg in the fed state. The incidence of adverse 
      events (AEs) was similar between the fasted and fed states, and no serious AEs 
      were observed. Food significantly increased the exposure to rivaroxaban 10 mg in 
      Chinese subjects.
CI  - (c) 2023, The American College of Clinical Pharmacology.
FAU - Sun, Xue
AU  - Sun X
AD  - Department of Pharmacy, Hebei General Hospital, Shijiazhuang, China.
FAU - Song, Haojing
AU  - Song H
AD  - Department of Pharmacy, Hebei General Hospital, Shijiazhuang, China.
FAU - Liu, Huan
AU  - Liu H
AD  - Technology R&D Center, Tianjin Pharmaceutical Research Institute Pharmaceutical 
      Responsible Co., Ltd., Tianjin, China.
FAU - Qiu, Bo
AU  - Qiu B
AD  - Department of Pharmacy, Hebei General Hospital, Shijiazhuang, China.
FAU - Ding, Congyang
AU  - Ding C
AD  - Department of Pharmacy, Hebei General Hospital, Shijiazhuang, China.
FAU - Hu, Yiting
AU  - Hu Y
AD  - Department of Pharmacy, Hebei General Hospital, Shijiazhuang, China.
FAU - Bai, Wanjun
AU  - Bai W
AD  - Department of Pharmacy, Hebei General Hospital, Shijiazhuang, China.
FAU - Dong, Zhanjun
AU  - Dong Z
AD  - Department of Pharmacy, Hebei General Hospital, Shijiazhuang, China.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230923
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
RN  - 9NDF7JZ4M3 (Rivaroxaban)
SB  - IM
MH  - Female
MH  - Humans
MH  - Male
MH  - China
MH  - *Diet, High-Fat
MH  - Healthy Volunteers
MH  - *Rivaroxaban/adverse effects
MH  - Therapeutic Equivalency
OTO - NOTNLM
OT  - food
OT  - high fat
OT  - pharmacokinetics
OT  - rivaroxaban
OT  - safety
EDAT- 2023/09/23 11:42
MHDA- 2024/02/05 06:43
CRDT- 2023/09/23 04:43
PHST- 2023/06/27 00:00 [received]
PHST- 2023/08/29 00:00 [accepted]
PHST- 2024/02/05 06:43 [medline]
PHST- 2023/09/23 11:42 [pubmed]
PHST- 2023/09/23 04:43 [entrez]
AID - 10.1002/cpdd.1330 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2024 Feb;13(2):146-151. doi: 10.1002/cpdd.1330. Epub 
      2023 Sep 23.