PMID- 26663198
OWN - NLM
STAT- MEDLINE
DCOM- 20170921
LR  - 20221207
IS  - 1179-1926 (Electronic)
IS  - 0312-5963 (Linking)
VI  - 55
IP  - 7
DP  - 2016 Jul
TI  - Single- and Multiple-Dose Milnacipran Pharmacokinetics in Healthy Han Chinese 
      Volunteers.
PG  - 889-896
LID - 10.1007/s40262-015-0355-2 [doi]
AB  - BACKGROUND: The pharmacokinetics of milnacipran have been studied in Caucasian 
      subjects but not in Chinese subjects. METHODS: This single-center, open-label 
      study evaluated the pharmacokinetics and safety of oral milnacipran administered 
      as a randomized, three-way crossover, single-dose (25, 50 and 100 mg) and in 
      multiple doses for 8 days (up to 100 mg/day administered as 50 mg twice daily) in 
      Han Chinese healthy volunteers. Both the single- and multiple-dose studies 
      included 12 different adults (six males and six females), respectively. 
      Pharmacokinetic parameters for milnacipran were determined using WinNonlin 
      version 6.3. The safety evaluation included adverse events (AEs) assessed by 
      monitoring, physical examinations, vital signs, and clinical laboratory tests. 
      RESULTS: Plasma concentrations of milnacipran reached a time to maximum 
      concentration (t max) of 1.2-4.3 h after each single dose, and then declined, 
      with a mean half-life (t (1/2)) of 7.0-7.3 h over the dose range of 25-100 mg; the 
      area under the curve (AUC) and maximum concentration (C max) values increased in 
      a dose-proportional manner. After multiple doses, steady state was reached by day 
      4 and the accumulation was low, with an accumulation index <1.65. No significant 
      sex differences were observed in milnacipran pharmacokinetic parameters and, 
      additionally, no severe AEs were observed in the single- or multiple-dose 
      studies. The most common reported AEs were nausea, vomiting, dizziness and water 
      brash, which appears to be dose-related. CONCLUSION: Milnacipran was safe and 
      well-tolerated in healthy volunteers and displayed linear increase in the C max 
      and AUC values at doses ranging from 25 to 100 mg once daily.
FAU - Ruan, Can-Jun
AU  - Ruan CJ
AD  - Laboratory of Clinical Psychopharmacology, Beijing Key Lab of Mental Disorders, 
      Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Dewai 
      Avenue, Xicheng District, 100088, Beijing, China.
FAU - Li, An-Ning
AU  - Li AN
AD  - Laboratory of Clinical Psychopharmacology, Beijing Key Lab of Mental Disorders, 
      Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Dewai 
      Avenue, Xicheng District, 100088, Beijing, China.
FAU - Dong, Fang
AU  - Dong F
AD  - Laboratory of Clinical Psychopharmacology, Beijing Key Lab of Mental Disorders, 
      Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Dewai 
      Avenue, Xicheng District, 100088, Beijing, China.
FAU - Zhai, Yi-Min
AU  - Zhai YM
AD  - Laboratory of Clinical Psychopharmacology, Beijing Key Lab of Mental Disorders, 
      Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Dewai 
      Avenue, Xicheng District, 100088, Beijing, China.
FAU - Li, Wen-Biao
AU  - Li WB
AD  - Laboratory of Clinical Psychopharmacology, Beijing Key Lab of Mental Disorders, 
      Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Dewai 
      Avenue, Xicheng District, 100088, Beijing, China.
FAU - Wang, Chuan-Yue
AU  - Wang CY
AD  - Laboratory of Clinical Psychopharmacology, Beijing Key Lab of Mental Disorders, 
      Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Dewai 
      Avenue, Xicheng District, 100088, Beijing, China. wang.cy@163.net.
FAU - de Leon, Jose
AU  - de Leon J
AD  - Mental Health Research Center at Eastern State Hospital, Lexington, KY, USA.
AD  - Psychiatry and Neurosciences Research Group (CTS-549), Institute of 
      Neurosciences, University of Granada, Granada, Spain.
AD  - Biomedical Research Centre in Mental Health Net (CIBERSAM), Santiago Apostol 
      Hospital, University of the Basque Country, Vitoria, Spain.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PL  - Switzerland
TA  - Clin Pharmacokinet
JT  - Clinical pharmacokinetics
JID - 7606849
RN  - 0 (Antidepressive Agents)
RN  - 0 (Cyclopropanes)
RN  - G56VK1HF36 (Milnacipran)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antidepressive Agents/*pharmacokinetics
MH  - Area Under Curve
MH  - Asian People
MH  - Cross-Over Studies
MH  - Cyclopropanes/*pharmacokinetics
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Half-Life
MH  - Humans
MH  - Male
MH  - Metabolic Clearance Rate
MH  - Milnacipran
MH  - Young Adult
EDAT- 2015/12/15 06:00
MHDA- 2017/09/22 06:00
CRDT- 2015/12/15 06:00
PHST- 2015/12/15 06:00 [entrez]
PHST- 2015/12/15 06:00 [pubmed]
PHST- 2017/09/22 06:00 [medline]
AID - 10.1007/s40262-015-0355-2 [pii]
AID - 10.1007/s40262-015-0355-2 [doi]
PST - ppublish
SO  - Clin Pharmacokinet. 2016 Jul;55(7):889-896. doi: 10.1007/s40262-015-0355-2.