PMID- 28941196
OWN - NLM
STAT- MEDLINE
DCOM- 20190613
LR  - 20221207
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Print)
IS  - 2160-763X (Linking)
VI  - 7
IP  - 3
DP  - 2018 Mar
TI  - Pharmacokinetics, Safety, and Tolerability of Vortioxetine Following Single- and 
      Multiple-Dose Administration in Healthy Japanese Adults.
PG  - 319-331
LID - 10.1002/cpdd.381 [doi]
AB  - Three phase 1 randomized single-center studies assessed the pharmacokinetics, 
      safety, and tolerability of vortioxetine after single- and multiple-dose 
      administration in healthy Japanese adults. Study 1 assessed the pharmacokinetics 
      of vortioxetine after administration of single rising doses to men and multiple 
      doses to men and women; study 2 evaluated vortioxetine pharmacokinetics in 
      elderly adults; and study 3 assessed food effects on vortioxetine 
      pharmacokinetics in healthy men. The primary end points included pharmacokinetic 
      parameters of vortioxetine and incidence of adverse events (AEs). Across all 
      studies, 130 participants were randomized and 128 participants completed the 
      studies. Vortioxetine was absorbed and eliminated from plasma slowly, and 
      exposure to vortioxetine increased in an almost dose-proportional manner. No 
      clinically significant differences in the pharmacokinetics of vortioxetine or its 
      metabolites were observed between the sexes in young and elderly adults. Study 3 
      demonstrated that vortioxetine and its metabolites had similar pharmacokinetics 
      when administered in the fasted and fed states. Importantly, vortioxetine was 
      safe and tolerated, with incidence of AEs comparable to that of placebo. No 
      deaths or serious AEs leading to trial discontinuation were observed. Overall, 
      vortioxetine pharmacokinetics, safety, and tolerability in Japanese adults were 
      comparable to reports in non-Japanese populations.
CI  - (c) 2017 The Authors. Clinical Pharmacology in Drug Development Published by Wiley 
      Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.
FAU - Matsuno, Kumi
AU  - Matsuno K
AD  - Takeda Pharmaceutical Company Limited.
FAU - Nakamura, Koki
AU  - Nakamura K
AD  - Takeda Pharmaceutical Company Limited.
FAU - Aritomi, Yutaka
AU  - Aritomi Y
AD  - Takeda Pharmaceutical Company Limited.
FAU - Nishimura, Akira
AU  - Nishimura A
AD  - Takeda Pharmaceutical Company Limited.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170921
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
RN  - 0 (Antidepressive Agents)
RN  - 3O2K1S3WQV (Vortioxetine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antidepressive Agents/*administration & dosage/*pharmacokinetics
MH  - *Asian People/genetics
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Food-Drug Interactions/physiology
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Vortioxetine/*administration & dosage/*pharmacokinetics
MH  - Young Adult
PMC - PMC5900865
OTO - NOTNLM
OT  - 5-HT
OT  - antidepressant
OT  - major depressive disorder
OT  - multimodal treatment
OT  - vortioxetine
EDAT- 2017/09/25 06:00
MHDA- 2019/06/14 06:00
PMCR- 2018/04/16
CRDT- 2017/09/24 06:00
PHST- 2017/02/02 00:00 [received]
PHST- 2017/06/28 00:00 [accepted]
PHST- 2017/09/25 06:00 [pubmed]
PHST- 2019/06/14 06:00 [medline]
PHST- 2017/09/24 06:00 [entrez]
PHST- 2018/04/16 00:00 [pmc-release]
AID - CPDD381 [pii]
AID - 10.1002/cpdd.381 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2018 Mar;7(3):319-331. doi: 10.1002/cpdd.381. Epub 2017 
      Sep 21.