Pharmacokinetic and Bioequivalence Evaluation of Two Cefprozil Dispersible Tablets in Healthy Chinese Volunteers.
bioequivalence
cefprozil
clinical trial
pharmacokinetics
safety
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
received:
09
05
2023
accepted:
26
06
2023
medline:
4
12
2023
pubmed:
21
7
2023
entrez:
21
7
2023
Statut:
ppublish
Résumé
This study aimed to assess the bioequivalence of 2 cefprozil dispersible tablet formulations (250 mg) in healthy Chinese volunteers under fasting and fed conditions and to determine the pharmacokinetics of cefprozil. A randomized, single-dose, open-label, 2-formulation, 2-period study was conducted. The elimination period for this study was 7 days. Forty-eight healthy volunteers received 250-mg cefprozil dispersible tablets in each study period under both test and reference conditions. The test and the reference cefprozil were bioequivalent in healthy Chinese volunteers, and there was no significant food effect in individuals receiving either formulation. No serious adverse event was recorded, and no volunteers withdrew from the study.
Substances chimiques
Tablets
0
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1229-1233Informations de copyright
© 2023, The American College of Clinical Pharmacology.
Références
Wiseman LR, Benfield P. Cefprozil. A review of its antibacterial activity, pharmacokinetic properties, and therapeutic potential. Drugs. 1993;45(2):295-317.
Perry CM, Scott LJ. Cefdinir: a review of its use in the management of mild-to-moderate bacterial infections. Drugs. 2004;64(13):1433-1464.
Lin PP, Wang CJ, Liu YP, et al. Pharmacokinetics and bioequivalence of cefprozil for suspension and granule formulation in healthy Chinese volunteers: two single-dose crossover studies. Adv Ther. 2021;38(2):1130-1142.
Park TH, Kim JK, Jee JP, Park JS, Kim CK. HPLC method for simultaneous determination of cefprozil diastereomers in human plasma. J Pharm Biomed Anal. 2004;36(1):243-248.
Nolen TM. Clinical trials of cefprozil for treatment of skin and skin-structure infections: review. Clin Infect Dis. 1992;14 suppl 2:S255-63; discussion S272.
Ball P. Efficacy and safety of cefprozil versus other beta-lactam antibiotics in the treatment of lower respiratory tract infections. Eur J Clin Microbiol Infect Dis. 1994;13(10):851-856.
Milatovic D, Adam D, Hamilton H, Materman E. Cefprozil versus penicillin V in treatment of streptococcal tonsillopharyngitis. Antimicrob Agents Chemother. 1993;37(8):1620-1623.
Adelglass J, Bundy JM, Woods R. Efficacy and tolerability of cefprozil versus amoxicillin/clavulanate for the treatment of adults with severe sinusitis. Clin Ther. 1998;20(6):1115-1129.
Nicolau DP, Sutherland CA, Arguedas A, Dagan R, Pichichero ME. Pharmacokinetics of cefprozil in plasma and middle ear fluid: in children undergoing treatment for acute otitis media. Paediatr Drugs. 2007;9(2):119-123.
Pistiki A, Tsaganos T, Galani I, Giamarellos-Bourboulis EJ. In vitro activity of oral cephalosporins (cefprozil and cefixime) against ciprofloxacin-resistant Enterobacteriaceae from community-acquired urinary-tract infections. Infect Dis Ther. 2015;4(4):425-432.
Barriere SL. Review of in vitro activity, pharmacokinetic characteristics, safety, and clinical efficacy of cefprozil, a new oral cephalosporin. Ann Pharmacother. 1993;27(9):1082-1089.
Barbhaiya RH, Shukla UA, Gleason CR, et al. Phase I study of multiple-dose cefprozil and comparison with cefaclor. Antimicrob Agents Chemother. 1990;34(6):1198-1203.
Barbhaiya RH, Gleason CR, Shyu WC, Wilber RB, Martin RR, Pittman KA. Phase I study of single-dose BMY-28100, a new oral cephalosporin. Antimicrob Agents Chemother. 1990;34(2):202-205.
Bhargava S, Lodha R, Kabra SK. Cefprozil: a review. Indian J Pediatr. 2003;70(5):395-400.
Lehmacher W. Analysis of the crossover design in the presence of residual effects. Stat Med. 1991;10(6):891-899.