PMID- 18498914
OWN - NLM
STAT- MEDLINE
DCOM- 20081118
LR  - 20190923
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 30
IP  - 4
DP  - 2008 Apr
TI  - Pharmacokinetic and bioequivalence comparison of a single 100-mg dose of cefteram 
      pivoxil powder suspension and tablet formulations: a randomized-sequence, 
      open-label, two-period crossover study in healthy Chinese adult male volunteers.
PG  - 654-60
AB  - BACKGROUND: Cefteram pivoxil (CFTM-PI) is an oral antibiotic available in powder 
      suspension and tablet formulations indicated in China for the treatment of 
      bacterial infections. Although these 2 formulations are marketed in China, 
      published information regarding their pharmacokinetics and bioequivalence in the 
      Chinese population is not available. OBJECTIVE: The aim of this study was to 
      compare the pharmacokinetics and bioequivalence of the powder suspension (test) 
      and tablet (reference) formulations of CFTM-PI 100 mg available in China. 
      METHODS: This single-dose, randomized-sequence, open-label, 2-period crossover 
      study was performed at the Nanjing First Hospital of Nanjing Medical University. 
      Eligible subjects were healthy male volunteers who were randomly assigned at a 
      1:1 ratio to receive a single 100-mg dose of the test or reference formulation, 
      followed by a 1-week washout period and administration of the alternate 
      formulation. The study drugs were administered after a 12-hour overnight fast. 
      Plasma was assayed using a high-performance liquid chromatography method. For 
      analysis of pharmacokinetic properties, including C(max), AUC from time 0 
      (baseline) to 6 hours (AUC(0-6)), and AUC from baseline to infinity 
      (AUC(0-infinity)), blood samples were obtained at intervals over the 6-hour 
      period after study drug administration. The formulations were considered 
      bioequivalent if the log-transformed ratios of C(max) and AUC were within the 
      predetermined equivalence range (80%-125%) as established by the US Food and Drug 
      Administration (FDA). Tolerability was assessed by monitoring vital signs and 
      laboratory tests (hematology, blood biochemistry, hepatic function, and 
      urinalysis), and by questioning subjects about adverse events (AEs). RESULTS: 
      Twenty-four Chinese male subjects (mean [range] age,24.2 [23-32] 
      years;weight,64.3 [58-67] kg; height, 172 [167-185] cm) enrolled; all completed 
      the study. No period or sequence effect was observed. The 90% CIs for the 
      log-transformed ratios of C(max), AUC(0-6;), and AUC(0-infinity) were 96.5 to 
      120.1, 95.7 to 110.2, and 96.2 to 110.4, respectively (all, P>0.05). Similar 
      results were found for the data without log-transformation. No AEs occurred or 
      were reported during the study. CONCLUSIONS: In this small study in healthy 
      Chinese adult male volunteers, a single 100-mg dose of the powder-suspension 
      formulation was bioequivalent to a single 100-mg dose of the tablet formulation 
      based on the US FDA's regulatory definition (rate and extent of absorption). Both 
      formulations were well tolerated.
FAU - Zou, Jianjun
AU  - Zou J
AD  - Department of Clinical Pharmacology, Nanjing First Hospital of Nanjing Medical 
      University, Nanjing, China.
FAU - Di, Bin
AU  - Di B
FAU - Wu, Chun Yong
AU  - Wu CY
FAU - Hu, Qin
AU  - Hu Q
FAU - Li, Jian Hua
AU  - Li JH
FAU - Zhu, Yubing
AU  - Zhu Y
FAU - Fan, Hongwei
AU  - Fan H
FAU - Xiao, DaWei
AU  - Xiao D
FAU - Wang, Guang Ji
AU  - Wang GJ
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Powders)
RN  - 0 (Tablets)
RN  - 0OD86RT58C (cefteram pivoxil)
RN  - KBZ4844CXN (Cefmenoxime)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Bacterial Infections/blood/drug therapy
MH  - Cefmenoxime/administration & dosage/*analogs & derivatives/pharmacokinetics
MH  - China
MH  - Chromatography, High Pressure Liquid
MH  - Cross-Over Studies
MH  - Dose-Response Relationship, Drug
MH  - Drug Compounding
MH  - Drug Tolerance
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Powders
MH  - Reference Values
MH  - Tablets
MH  - Therapeutic Equivalency
EDAT- 2008/05/24 09:00
MHDA- 2008/11/19 09:00
CRDT- 2008/05/24 09:00
PHST- 2008/02/21 00:00 [accepted]
PHST- 2008/05/24 09:00 [pubmed]
PHST- 2008/11/19 09:00 [medline]
PHST- 2008/05/24 09:00 [entrez]
AID - S0149-2918(08)00142-2 [pii]
AID - 10.1016/j.clinthera.2008.04.003 [doi]
PST - ppublish
SO  - Clin Ther. 2008 Apr;30(4):654-60. doi: 10.1016/j.clinthera.2008.04.003.