Dermal effects and pharmacokinetic evaluation of the lidocaine/prilocaine cream in healthy Chinese volunteers.
Dermal Effects
EMLA
Pharmacokinetic Evaluation
Journal
BMC pharmacology & toxicology
ISSN: 2050-6511
Titre abrégé: BMC Pharmacol Toxicol
Pays: England
ID NLM: 101590449
Informations de publication
Date de publication:
12 10 2023
12 10 2023
Historique:
received:
06
03
2023
accepted:
19
09
2023
medline:
1
11
2023
pubmed:
13
10
2023
entrez:
12
10
2023
Statut:
epublish
Résumé
EMLA cream is a local anesthetic. The pharmacokinetics and dermal effects of a topical anesthetic formulation has not been evaluated in healthy Chinese volunteers. The Pharmacokinetics of the lidocaine/prilocaine test (T) or reference (R, EMLA) cream were evaluated in a fasting, single-dose, two-period crossover bioequivalent study conducted in 40 healthy Chinese volunteers. Meanwhile, the dermal effects including blanching, erythema, temperature sensation, edema, and skin rash were also evaluated during the study. After applied 15 g of the cream for 4 h to a 100 cm The method described a model for investigations of pharmacokinetics and pharmacodynamics of topical lidocaine/prilocaine cream. Except the plasma drug level indicator, these pharmacodynamics data should also be evaluated in the anesthetic transdermal pharmacokinetics study. CTR20211544; registered in http://www.chinadrugtrials.org.cn/ at September 2021.
Sections du résumé
BACKGROUND
EMLA cream is a local anesthetic. The pharmacokinetics and dermal effects of a topical anesthetic formulation has not been evaluated in healthy Chinese volunteers.
MATERIALS AND METHODS
The Pharmacokinetics of the lidocaine/prilocaine test (T) or reference (R, EMLA) cream were evaluated in a fasting, single-dose, two-period crossover bioequivalent study conducted in 40 healthy Chinese volunteers. Meanwhile, the dermal effects including blanching, erythema, temperature sensation, edema, and skin rash were also evaluated during the study.
RESULTS
After applied 15 g of the cream for 4 h to a 100 cm
CONCLUSION
The method described a model for investigations of pharmacokinetics and pharmacodynamics of topical lidocaine/prilocaine cream. Except the plasma drug level indicator, these pharmacodynamics data should also be evaluated in the anesthetic transdermal pharmacokinetics study.
CLINICAL TRIAL REGISTRATION
CTR20211544; registered in http://www.chinadrugtrials.org.cn/ at September 2021.
Identifiants
pubmed: 37828535
doi: 10.1186/s40360-023-00690-x
pii: 10.1186/s40360-023-00690-x
pmc: PMC10571248
doi:
Substances chimiques
Lidocaine, Prilocaine Drug Combination
0
Drug Combinations
0
Anesthetics, Local
0
Prilocaine
046O35D44R
Lidocaine
98PI200987
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
51Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
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