PMID- 33609057
OWN - NLM
STAT- MEDLINE
DCOM- 20211216
LR  - 20211216
IS  - 1440-1681 (Electronic)
IS  - 0305-1870 (Linking)
VI  - 48
IP  - 5
DP  - 2021 May
TI  - Evaluation of bioequivalence of two flurbiprofen axetil injections: A randomized, 
      open-label, double-cycle, and crossover study.
PG  - 660-667
LID - 10.1111/1440-1681.13479 [doi]
AB  - Flurbiprofen is a non-steroidal anti-inflammatory drug. We evaluated the 
      bioequivalence of a new formulation of flurbiprofen axetil for injection and the 
      reference drug ROPION (another kind of flurbiprofen axetil injection marketed for 
      use) in healthy Chinese subjects. This is a single-centre, randomized, 
      open-label, single-dose, two period crossover bioequivalence study. Each subject 
      received a single intravenous injection at the dose of 50 mg under fasting. The 
      drug was dissolved in 100 mL normal saline, and the injection was completed in 
      15 minutes. There was a 7-day washout period between the two administrations. The 
      plasma concentrations of flurbiprofen were measured by LC-MS/MS, and descriptive 
      statistics were used to describe the safety outcomes including adverse events 
      (AEs) and adverse drug reactions (ADRs). Twenty-four subjects were enrolled in 
      this study. Mean values of primary PK parameters (T(max) , C(max) , AUC(0-t) , 
      AUC(0-infinity) , lambda(z) , T(1/2) ) were similar (P > 0.05). T(max) for both products is 
      0.3 hours. The 90% confidence intervals (CIs) for peak concentration C(max) 
      ranged between 96.87% and 100.42%, and the area under curve AUC(0-t) and AUC(0-infinity) 
      ranged between 99.09% and 104.29% and 98.97% and 104.29%, respectively. The 90% 
      CIs for the geometric means and ratios of primary PK endpoints of flurbiprofen 
      axetil injection to reference drug ranged between 98.97% and 104.29%. The adverse 
      event rate of the test product was 8.3% and no serious adverse events (SAE) 
      occurred in this clinical study. We concluded that the test product and the 
      reference drug were bioequivalent and the safety was high in healthy Chinese 
      subjects.
CI  - (c) 2021 John Wiley & Sons Australia, Ltd.
FAU - Wang, Jin
AU  - Wang J
AD  - Department of Pharmacy, Center of Medicine Clinical Research, Chinese PLA General 
      Hospital, Beijing, China.
FAU - Dong, Liuhan
AU  - Dong L
AUID- ORCID: 0000-0002-2617-4792
AD  - Department of Pharmacy, Center of Medicine Clinical Research, Chinese PLA General 
      Hospital, Beijing, China.
AD  - Medical School of Chinese PLA, Beijing, China.
FAU - Wang, Rui
AU  - Wang R
AD  - Department of Pharmacy, Center of Medicine Clinical Research, Chinese PLA General 
      Hospital, Beijing, China.
FAU - Cai, Yun
AU  - Cai Y
AD  - Department of Pharmacy, Center of Medicine Clinical Research, Chinese PLA General 
      Hospital, Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20210220
PL  - Australia
TA  - Clin Exp Pharmacol Physiol
JT  - Clinical and experimental pharmacology & physiology
JID - 0425076
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 5GRO578KLP (Flurbiprofen)
RN  - I0OU31PUI5 (flurbiprofen axetil)
SB  - IM
MH  - Anti-Inflammatory Agents, Non-Steroidal
MH  - Cross-Over Studies
MH  - Flurbiprofen/*analogs & derivatives
OTO - NOTNLM
OT  - adverse effects
OT  - bioequivalence
OT  - flurbiprofen
OT  - pharmacokinetics
EDAT- 2021/02/21 06:00
MHDA- 2021/12/17 06:00
CRDT- 2021/02/20 08:33
PHST- 2020/07/22 00:00 [revised]
PHST- 2020/10/27 00:00 [received]
PHST- 2021/01/24 00:00 [accepted]
PHST- 2021/02/21 06:00 [pubmed]
PHST- 2021/12/17 06:00 [medline]
PHST- 2021/02/20 08:33 [entrez]
AID - 10.1111/1440-1681.13479 [doi]
PST - ppublish
SO  - Clin Exp Pharmacol Physiol. 2021 May;48(5):660-667. doi: 10.1111/1440-1681.13479. 
      Epub 2021 Feb 20.