PMID- 36808267
OWN - NLM
STAT- MEDLINE
DCOM- 20230405
LR  - 20230406
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Linking)
VI  - 12
IP  - 4
DP  - 2023 Apr
TI  - Three-Period Bioequivalence Study of Sodium Levofolinate Injection With Calcium 
      Levofolinate for Injection and Sodium Folinate for Injection in Healthy Chinese 
      Subjects.
PG  - 416-423
LID - 10.1002/cpdd.1223 [doi]
AB  - The aim of this study was to compare the bioequivalence and safety of test 
      preparation sodium levofolinate injection with reference preparations of calcium 
      levofolinate for injection and sodium folinate for injection in China. A 
      single-center, randomized, open-label, 3-period, crossover test was conducted on 
      24 healthy subjects. Plasma concentration of levofolinate, dextrofolinate, and 
      their metabolites l-5-methyltetrahydrofolate and d-5-methyltetrahydrofolate were 
      quantified by a validated chiral-liquid chromatography-tandem mass spectrometry 
      method. All adverse events (AEs) were documented to evaluate safety as they 
      occurred and evaluated descriptively. Pharmacokinetic parameters (maximum plasma 
      concentration, time to maximum concentration, area under the plasma 
      concentration-time curve over the dosing interval, area under the plasma 
      concentration-time curve from time 0 to infinity, terminal elimination half-life, 
      and terminal rate constant) of 3 preparations were calculated. A total of 8 
      subjects (10 cases) of AEs occurred in this trial. No serious AEs or unexpected 
      serious adverse reactions were observed. Sodium levofolinate was bioequivalent to 
      calcium levofolinate and sodium folinate in Chinese subjects, and the 3 
      preparations were all well tolerated.
CI  - (c) 2023 The Authors. Clinical Pharmacology in Drug Development published by Wiley 
      Periodicals LLC on behalf of American College of Clinical Pharmacology.
FAU - Qiu, Benfeng
AU  - Qiu B
AD  - School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of 
      China.
FAU - Liu, Gege
AU  - Liu G
AD  - School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of 
      China.
FAU - Wang, Changmao
AU  - Wang C
AD  - School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of 
      China.
FAU - Chen, Xinyan
AU  - Chen X
AD  - School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of 
      China.
FAU - Liu, Ran
AU  - Liu R
AD  - School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of 
      China.
FAU - Huang, Yunzhe
AU  - Huang Y
AD  - School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of 
      China.
FAU - Jia, Yuanwei
AU  - Jia Y
AD  - Anhui Provincial Center of Drug Clinical Evaluation, Yijishan Hospital of Wannan 
      Medical College, Wuhu, Anhui, People's Republic of China.
FAU - Shen, Jie
AU  - Shen J
AD  - School of Pharmacy, Wannan Medical College, Wuhu, Anhui, People's Republic of 
      China.
AD  - Anhui Provincial Center of Drug Clinical Evaluation, Yijishan Hospital of Wannan 
      Medical College, Wuhu, Anhui, People's Republic of China.
LA  - eng
PT  - Equivalence Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230219
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
RN  - 990S25980Y (Levoleucovorin)
RN  - Q573I9DVLP (Leucovorin)
SB  - IM
MH  - Humans
MH  - *East Asian People
MH  - Healthy Volunteers
MH  - Therapeutic Equivalency
MH  - *Levoleucovorin/chemistry/pharmacokinetics
MH  - *Leucovorin/chemistry/pharmacokinetics
OTO - NOTNLM
OT  - bioequivalence
OT  - l-formyltetrahydrofolate
OT  - metabolites
OT  - pharmacokinetics
OT  - safety
EDAT- 2023/02/23 06:00
MHDA- 2023/04/04 06:42
CRDT- 2023/02/22 12:44
PHST- 2022/09/12 00:00 [received]
PHST- 2022/12/22 00:00 [accepted]
PHST- 2023/04/04 06:42 [medline]
PHST- 2023/02/23 06:00 [pubmed]
PHST- 2023/02/22 12:44 [entrez]
AID - 10.1002/cpdd.1223 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2023 Apr;12(4):416-423. doi: 10.1002/cpdd.1223. Epub 
      2023 Feb 19.