PMID- 36815228
OWN - NLM
STAT- MEDLINE
DCOM- 20230703
LR  - 20240416
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Linking)
VI  - 12
IP  - 7
DP  - 2023 Jul
TI  - A Bioequivalence Study With Pharmacokinetic Endpoints for Azithromycin Eye Drops.
PG  - 761-766
LID - 10.1002/cpdd.1226 [doi]
AB  - Azithromycin eye drops with a bioadhesive ocular drug-delivery system can offer a 
      simplified dosing regimen. In this study, we compared the pharmacokinetic 
      properties and assessed the bioequivalence of a newly developed generic 
      azithromycin eye drop with a branded formulation. This open-label, single-dose, 
      randomized, crossover, sparse-sampling ocular bioequivalence study was conducted 
      on 48 healthy Chinese volunteers. Tear samples were collected for up to 36 hours, 
      and each participant was randomly allocated to one of the prespecified sampling 
      times. Tear drug concentrations were determined using a validated liquid 
      chromatography-tandem mass spectrometry method. The pharmacokinetic parameters 
      were calculated via noncompartmental analysis. A nonparametric bootstrap method 
      was used to obtain 90% confidence intervals (CIs) for the ratios of the test and 
      reference drugs. Tolerability was evaluated for adverse events (AEs). After 
      bootstrapping (1000 iterations), the 90%CIs for the log-transformed ratios of 
      C(max) , AUC(0-t) , and AUC(0-infinity) were within the acceptable bioequivalence range 
      (80%-125%). No moderate-to-severe AEs were reported for either formulation. 
      Bioequivalence was demonstrated between the two formulations. The sparse-sampling 
      design with the bootstrapping technique is promising for bioequivalence studies 
      of topical ophthalmic drugs.
CI  - (c) 2023, The American College of Clinical Pharmacology.
FAU - Wu, Feng
AU  - Wu F
AD  - National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital 
      Medical University, Beijing, China.
FAU - Zhao, Xiuli
AU  - Zhao X
AD  - National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital 
      Medical University, Beijing, China.
FAU - Guo, Shaojie
AU  - Guo S
AD  - National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital 
      Medical University, Beijing, China.
FAU - Ni, Siyang
AU  - Ni S
AD  - National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital 
      Medical University, Beijing, China.
FAU - Dai, Yuyang
AU  - Dai Y
AD  - National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital 
      Medical University, Beijing, China.
FAU - Han, Ying
AU  - Han Y
AD  - National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital 
      Medical University, Beijing, China.
FAU - Ma, Ke
AU  - Ma K
AD  - National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital 
      Medical University, Beijing, China.
FAU - Wang, Yunzhe
AU  - Wang Y
AD  - Essex Bio-Technology Limited, Zhuhai, Guangdong, China.
LA  - eng
GR  - 2011ZX09302-007-05/Chinese National Major Scientific and Technological Special 
      Project for Significant New Drug Development/
GR  - Z191100007619038/Beijing Science and Technology Planning Project/
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230222
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
RN  - 83905-01-5 (Azithromycin)
RN  - 0 (Drugs, Generic)
SB  - IM
MH  - Humans
MH  - *Azithromycin/adverse effects
MH  - Therapeutic Equivalency
MH  - Chromatography, Liquid
MH  - *Drugs, Generic/pharmacokinetics
MH  - Tandem Mass Spectrometry/methods
MH  - Cross-Over Studies
OTO - NOTNLM
OT  - azithromycin eye drops
OT  - bioequivalence
OT  - bootstrapping
OT  - ocular pharmacokinetics
OT  - sparse sampling
EDAT- 2023/02/24 06:00
MHDA- 2023/07/03 06:41
CRDT- 2023/02/23 02:43
PHST- 2022/11/20 00:00 [received]
PHST- 2023/01/16 00:00 [accepted]
PHST- 2023/07/03 06:41 [medline]
PHST- 2023/02/24 06:00 [pubmed]
PHST- 2023/02/23 02:43 [entrez]
AID - 10.1002/cpdd.1226 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2023 Jul;12(7):761-766. doi: 10.1002/cpdd.1226. Epub 
      2023 Feb 22.