Comparative bioavailability and safety of two intramuscular ceftriaxone formulations

被引:1
作者
Suarez, EC
Grippi, JR
机构
[1] HOFFMANN LA ROCHE INC,DEPT CLIN SERV PROFESS SERV,NUTLEY,NJ 07110
[2] HOFFMANN LA ROCHE INC,DEPT OUTCOMES MANAGEMENT & PAYMENT PLANNING,NUTLEY,NJ 07110
关键词
D O I
10.1177/106002809603001101
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
OBJECTIVE: To determine if two ceftriaxone solutions of different concentrations are bioequivalent when administered intramuscularly. DESIGN: Double-blind, single-dose, two-period, randomized crossover study. SETTING: A clinical research center. SUBJECTS: Seventeen healthy volunteers. INTERVENTION: Ceftriaxone 500 mg administered in either 2 or 1.4 mL of lidocaine 1% solution, with final ceftriaxone concentrations of 250 and 350 mg/mL, respectively. MAIN OUTCOME MEASURES: Blood samples were assayed for ceftriaxone concentrations with HPLC and pharmacokinetic parameters were calculated from the resulting plasma-concentration time profiles: maximum plasma concentration (C-max) of ceftriaxone and areas under the concentration-time curve (AUC) from 0 to 36 h and 0 to infinity were the primary parameters considered in the determination of bioequivalence. RESULTS: The two solutions were generally well tolerated and had similar safety profiles. Administration of both solutions resulted in similar mean values for all pharmacokinetic parameters. Statistical analysis showed no significant differences between the two solutions in any pharmacokinetic parameter, indicating that the two solutions are statistically bioequivalent (p less than or equal to 0.05). The 90% CI for the ratio of the means for AUC(0-36) (0.86 to 1.11), AUC(infinity) (0.89 to 1.14), and C-max (0.84 to 1.12) are within the Food and Drug Administration range of bioequivalence (0.80 to 1.25). CONCLUSIONS: These results demonstrate that the more concentrated solution of ceftriaxone (350 mg/mL) is bioequivalent to the currently marketed solution of 250 mg/mL.
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页码:1223 / 1226
页数:4
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