PMID- 25173761
OWN - NLM
STAT- MEDLINE
DCOM- 20160912
LR  - 20221207
IS  - 2107-0180 (Electronic)
IS  - 0378-7966 (Linking)
VI  - 40
IP  - 4
DP  - 2015 Dec
TI  - Tolerability and pharmacokinetics of disodium folinate following single 
      intravenous doses in healthy Chinese subjects: an open-label, randomized, 
      single-center study.
PG  - 443-51
LID - 10.1007/s13318-014-0222-9 [doi]
AB  - The tolerability and pharmacokinetics of disodium folinate may vary with 
      different races, and these variations might result in different outcomes. This 
      study assessed the tolerability and pharmacokinetics of disodium folinate 
      following single intravenous doses in healthy Chinese subjects, with gender 
      factor also taken into account. Subjects were randomized to receive a single dose 
      of disodium folinate at 20, 200, or 300 mg/m(2) administered intravenously over a 
      time period of 10 min. Sequential blood samples were collected at regular 
      intervals over 24 h after dosing and were analyzed using a validated 
      high-performance liquid chromatography (HPLC) method. Pharmacokinetic parameters, 
      including C max, AUC0-t, t 1/2, V d, and CL, were calculated using 
      non-compartmental models. Tolerability was assessed by collecting adverse events 
      (AEs) and monitoring vital signs, physical examinations, laboratory tests, and 
      electrocardiograms. Following a single intravenous administration of disodium 
      folinate 20, 200, and 300 mg/m(2), the mean (standard deviation) pharmacokinetic 
      parameters were as follows: C max = 5.18 (0.58), 47.80 (10.10), and 69.93 
      (9.72) microg/mL; AUC0-t = 25.85 (3.36), 194.53 (30.18), and 355.26 (35.31) microg h/mL; 
      AUC0-infinity = 30.24 (6.19), 215.43 (27.34), and 417.88 (54.81) microg h/mL; t 1/2 = 8.77 
      (2.57), 7.64 (1.81), and 9.08 (1.64) h; CL = 1.12 (0.18), 1.55(0.25), and 0.78 
      (0.09) L/h; V d = 13.75 (2.61), 17.38 (6.44), and 10.05 (1.49) L, respectively. 
      The mean C max, AUC0-t, and AUC0-infinity increased in a dose-proportional manner. No 
      significant differences in pharmacokinetic parameters were noted by gender. The 
      most common AEs reported were mild redness at the injection site and neurological 
      symptoms (headache, dizziness, and fatigue).
FAU - Liu, Yani
AU  - Liu Y
AD  - Clinical Research Organization for Pharmaceutical Products, Union Hospital, 
      Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 
      China. yani_liu@hotmail.com.
FAU - Zhou, Jiali
AU  - Zhou J
AD  - Clinical Research Organization for Pharmaceutical Products, Union Hospital, 
      Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 
      China.
FAU - Li, Zhongfang
AU  - Li Z
AD  - Clinical Research Organization for Pharmaceutical Products, Union Hospital, 
      Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 
      China.
FAU - Yang, Chunxiao
AU  - Yang C
AD  - Clinical Research Organization for Pharmaceutical Products, Union Hospital, 
      Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 
      China.
FAU - Wu, Jianhong
AU  - Wu J
AD  - Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University 
      of Science and Technology, Wuhan, China.
FAU - Zhang, Yu
AU  - Zhang Y
AD  - Clinical Research Organization for Pharmaceutical Products, Union Hospital, 
      Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 
      China.
FAU - Shi, Shaojun
AU  - Shi S
AD  - Clinical Research Organization for Pharmaceutical Products, Union Hospital, 
      Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 
      China.
FAU - Li, Yunqiao
AU  - Li Y
AD  - Department of Geriatrics, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China. li_yunqiao@126.com.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140831
PL  - France
TA  - Eur J Drug Metab Pharmacokinet
JT  - European journal of drug metabolism and pharmacokinetics
JID - 7608491
RN  - 9NEZ333N27 (Sodium)
RN  - Q573I9DVLP (Leucovorin)
SB  - IM
MH  - Administration, Intravenous
MH  - Adult
MH  - *Asian People
MH  - Dizziness/chemically induced
MH  - Female
MH  - Headache/chemically induced
MH  - Healthy Volunteers
MH  - Humans
MH  - Leucovorin/*administration & dosage/*adverse effects/blood
MH  - Male
MH  - Sodium/administration & dosage/adverse effects/blood
MH  - Young Adult
OTO - NOTNLM
OT  - Chinese subjects
OT  - Disodium folinate
OT  - Pharmacokinetics
OT  - Tolerability
EDAT- 2014/09/01 06:00
MHDA- 2016/09/13 06:00
CRDT- 2014/09/01 06:00
PHST- 2014/05/07 00:00 [received]
PHST- 2014/08/18 00:00 [accepted]
PHST- 2014/09/01 06:00 [entrez]
PHST- 2014/09/01 06:00 [pubmed]
PHST- 2016/09/13 06:00 [medline]
AID - 10.1007/s13318-014-0222-9 [pii]
AID - 10.1007/s13318-014-0222-9 [doi]
PST - ppublish
SO  - Eur J Drug Metab Pharmacokinet. 2015 Dec;40(4):443-51. doi: 
      10.1007/s13318-014-0222-9. Epub 2014 Aug 31.