PMID- 32753845
OWN - NLM
STAT- MEDLINE
DCOM- 20210604
LR  - 20221207
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 14
DP  - 2020
TI  - Evaluation of Bioequivalency and Pharmacokinetic Parameters for Two Formulations 
      of Glimepiride 1-mg in Chinese Subjects.
PG  - 2637-2644
LID - 10.2147/DDDT.S249355 [doi]
AB  - PURPOSE: Glimepiride, an FDA-approved oral hypoglycemic drug, is a long-acting 
      sulfonylurea (SU), used for treating type 2 diabetes. The study aimed to evaluate 
      the bioequivalence and safety profiles of two different formulations of 
      glimepiride 1 mg from two different manufactures in healthy Chinese subjects in 
      the fasting and fed state in order to acquire adequate pharmacokinetic evidence 
      for registration approval of the test formulation. PATIENTS AND METHODS: This 
      study is an open-label, two-period, two-sequence, randomized, two-way crossover 
      pharmacokinetic study in healthy Chinese subjects in the fasting and fed state. 
      Seventy-two subjects were randomly assigned to the fasting group and the fed 
      group (n=36 each). We collected blood samples, 24-h post drug administration. The 
      plasma concentration of glimepiride was assessed using HPLC coupled with mass 
      spectrometry. The following parameters were evaluated: AUC(0-inf), AUC(0-last), 
      C(max), t(1⁄2), T(max), and lambda(z). Safety was determined based on the occurrence 
      of adverse events (AEs) and laboratory examinations (biochemistry, hematology, 
      and urinalysis) throughout the entire study period. RESULTS: The geometric mean 
      ratios (GMR) amongst the two glimepiride formulations for the primary 
      pharmacokinetic parameters, ie, AUC(0-inf), AUC(0-last), and C(max) as well as 
      the corresponding 90% CIs, were all within the range of 80.00-125.00% in the 
      fasting and fed state. The safety profile for both treatments was comparable. 
      CONCLUSION: PK analysis revealed that the test and reference formulations of 
      glimepiride were bioequivalent and well tolerated in healthy Chinese subjects. 
      Chinese Clinical Trials Registry identifier: CTR20171121. CLINICAL TRIAL 
      REGISTRATION NUMBER: CTR20171121.
CI  - (c) 2020 Ju et al.
FAU - Ju, Gehang
AU  - Ju G
AD  - School of Pharmacy Lanzhou University, Lanzhou University, Lanzhou, People's 
      Republic of China.
FAU - Yan, Keyu
AU  - Yan K
AD  - School of Pharmacy Lanzhou University, Lanzhou University, Lanzhou, People's 
      Republic of China.
FAU - Xu, Youwei
AU  - Xu Y
AD  - Research Institute, Shandong Xinhua Pharmaceutical Company Limited, Shandong, 
      People's Republic of China.
FAU - Chen, Shilin
AU  - Chen S
AUID- ORCID: 0000-0003-3680-9066
AD  - The Department of Analysis, Chengdu Fanweixi Pharmaceutical Technology Company, 
      Limited, Chengdu, People's Republic of China.
FAU - Zheng, Zhonghui
AU  - Zheng Z
AD  - Research Institute, Shandong Xinhua Pharmaceutical Company Limited, Shandong, 
      People's Republic of China.
FAU - Qiu, Wen
AU  - Qiu W
AD  - Phase I Clinical Unit, Lanzhou University Second Hospital, Lanzhou, People's 
      Republic of China.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200706
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sulfonylurea Compounds)
RN  - 6KY687524K (glimepiride)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Asian People
MH  - Cross-Over Studies
MH  - Diabetes Mellitus, Type 2/drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Drug Compounding
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/blood/*pharmacokinetics
MH  - Male
MH  - Sulfonylurea Compounds/administration & dosage/blood/*pharmacokinetics
MH  - Therapeutic Equivalency
MH  - Young Adult
PMC - PMC7351633
OTO - NOTNLM
OT  - HPLC-MS/MS
OT  - adverse event
OT  - bioequivalence
OT  - glimepiride
OT  - pharmacokinetics
COIS- Youwei Xu and Zhonghui Zheng are employees of Shandong Xinhua Pharmaceutical 
      Company Limited. Shilin Chen is an employee of Chengdu Fanweixi Pharmaceutical 
      Technology Company, Limited. The authors report no other conflicts of interest in 
      this work.
EDAT- 2020/08/06 06:00
MHDA- 2021/06/05 06:00
PMCR- 2020/07/06
CRDT- 2020/08/06 06:00
PHST- 2020/02/12 00:00 [received]
PHST- 2020/06/09 00:00 [accepted]
PHST- 2020/08/06 06:00 [entrez]
PHST- 2020/08/06 06:00 [pubmed]
PHST- 2021/06/05 06:00 [medline]
PHST- 2020/07/06 00:00 [pmc-release]
AID - 249355 [pii]
AID - 10.2147/DDDT.S249355 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2020 Jul 6;14:2637-2644. doi: 10.2147/DDDT.S249355. 
      eCollection 2020.