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

Clinical Therapeutics

Volumn 30, Issue 4, 2008, Pages 654-660

  Zou, Jianjun ^a   Di, Bin ^b   Wu, Chun Yong ^a   Hu, Qin ^a   Li, Jian Hua ^c   Zhu, Yubing ^a   Fan, Hongwei ^a   Xiao, DaWei ^a   Wang, Guang Ji ^b  

^a NANJING MEDICAL UNIVERSITY   (China)

^b CHINA PHARMACEUTICAL UNIVERSITY   (China)

^c Simcere Pharmaceutical Group   (China)

Author keywords

bioavailability; bioequivalence; cefteram; Chinese; chromatography; high performance liquid; human plasma; pharmacokinetics; pivoxil

Indexed keywords

CEFTERAM PIVOXIL;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD CHEMISTRY; BLOOD SAMPLING; BODY HEIGHT; BODY WEIGHT; CHINA; CHINESE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM COMPARISON; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; HEMATOLOGY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LABORATORY TEST; LIVER FUNCTION; MALE; NORMAL HUMAN; OPEN STUDY; POWDER; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SUSPENSION; TABLET FORMULATION; UNIVERSITY HOSPITAL; URINALYSIS; VITAL SIGN;

EID: 43549102402     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2008.04.003     Document Type: Article

References (20)

1. H Sakata H Kakehashi K Fujita Clinical and pharmacokinetic evaluation of cefteram pivoxil in children [in Japanese] Jpn J Antibiot 42 1989 1727 1734
2. G Suzuki A Watanabe Laboratory and clinical studies on cefteram pivoxil in pediatric field [in Japanese] Jpn J Antibiot 42 1989 1751 1760
3. H Sato A Narita S Nakazawa Clinical studies on cefteram pivoxil granules in pediatrics [in Japanese] Jpn J Antibiot 42 1989 1948 1962
4. Y Toyonaga H Imai M Sugita Bacteriological, pharmacokinetic and clinical studies on cefteram pivoxil in the pediatric field [in Japanese] Jpn J Antibiot 42 1989 1799 1814
5. T Nishimura K Tabuki T Takashima Laboratory and clinical studies of cefteram pivoxil in pediatric field [in Japanese] Jpn J Antibiot 42 1989 2004 2015
6. Y Wagatsuma A Takase N Fukushima Clinical evaluation of cefteram pivoxil fine granules in pediatric infections [in Japanese] Jpn J Antibiot 42 1989 1735 1744
7. S Iwata K Yamada Y Kin The influence of cefteram pivoxil on the intestinal bacterial flora [in Japanese] Jpn J Antibiot 42 1989 1761 1779
8. RM Miyazaki N Muraki N Kohno Clinical evaluation of cefteram pivoxil in respiratory tract infections [in Japanese] Jpn J Antibiot 43 1990 326 336
9. K Yamaki H Watanabe K Takagi Clinical studies on cefteram pivoxil in the treatment of respiratory infections [in Japanese] Jpn J Antibiot 43 1990 81 88
10. S Okamoto Y Hamana M Inoue S Mitsuhashi In vitro and in vivo antibacterial activities of T-2588, a new oral cephalosporin, compared with those of other oral β-lactam antibiotics Antimicrob Agents Chemother 31 1987 1111 1116
11. World Medical Association (WMA). Declaration of Helsinki. Ethical principles for medical research involving human subjects [WMA Web site].
12. http://www.wma.net/e/policy/b3.htm August 16, 2006 Accessed
13. US Food and Drug Administration (FDA), Center for Drug Evaluation and Research. Guidance for industry. Bioanalytical method validation [FDA Web site].
14. http://www.fda.gov/cder/guidance/4252fnl.htm August 16, 2006 Accessed
15. US Food and Drug Administration In vivo bioequivalence guidances Pharmacopeial Forum 19 1993 6501 6508
16. DJ Schuirmann A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability J Pharmacokinet Biopharm 15 1987 657 680
17. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry. Statistical approaches to establishing bio-equivalence [FDA Web site].
18. http://www.fda.gov/Cder/guidance/3616fnl.htm August 16, 2006 Accessed
19. Statistical methods for average bioavailability and bioequivalence studies. S-C Chow J-P Liu Design and Analysis of Bioavailability and Bioequivalence Studies. 2nd ed 2000 Marcel Dekker New York, NY 79 124
20. Power and sample size determination. S-C Chow J-P Liu Design and Analysis of Bioavailability and Bioequivalence Studies. 2nd ed 2000 Marcel Dekker New York, NY 125 160