Safety, pharmacokinetics and influence on the intestinal flora of BAY 12-8039 (moxifloxacin hydrochloride) after oral administration in healthy male subjects

Japanese Pharmacology and Therapeutics

Volumn 33, Issue 10, 2005, Pages 1029-1045

  Ohnishi, Akihiro ^a   Toyoki, Takaaki ^b   Yoshikawa, Kenichi ^c   Hashizume, Kensei ^c   Tanigawa, Takahiko ^c   Tanaka, Toshiaki ^c   Komori, Tetsushi ^c  

^a JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b Toyoki Naika Clinic

^c BAYER YAKUHIN LTD   (Japan)

Author keywords

Healthy subjects; Intestinal flora; Moxifloxacin; New quinolone; Pharmacokinetics; Phase I study; Safety; Tolerability

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; LACTATE DEHYDROGENASE; MOXIFLOXACIN; PLACEBO; TRIACYLGLYCEROL LIPASE;

AREA UNDER THE CURVE; ARTICLE; BODY EQUILIBRIUM; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; ELECTROENCEPHALOGRAM; FECES; FOOD DRUG INTERACTION; HEADACHE; HUMAN; HUMAN EXPERIMENT; INTESTINE FLORA; MALE; MUDDY STOOL; MULTIPLE DRUG DOSE; NAUSEA; NORMAL HUMAN; OPHTHALMOLOGY; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; VITAL SIGN;

EID: 32844461168     PISSN: 03863603     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

1. Miyashita N, Fukano H, Yoshida K, Niki Y, Matsushima T. In-vitro activity of moxifloxacin and other fluoroquinolones against Chlamydia species. J Infect Chemother 2002; 8: 115-7.
2. Stass H, Kubitza D. Basic pharmacokinetics of moxifloxacin. Drugs 1999; 58 (Suppl 2): 225-6.
3. Stass H, Kubitza D. Pharmacokinetics and elimination of moxifloxacin after oral and intravenous administration in man. J Antimicrob Chemother 1999; 43 (Suppl B): 83-90.
4. Stass H, Proeve A. Pharmacokinetic/pharmacodynamic estimates for the treatment of community-aquired respiratory tract infections with moxifloxacin. Clin Microbiol Infect 1999; 5 (Suppl 3): 292 abstr 772.
5. Moeller J-G, Stass H, Muck W. Advances in bioanalytical methodology used to characterize clinical pharmacokinetics of moxifloxacin. Drugs 1999; 58 (Suppl 2): 237-8.
6. Al-Khatib SM, Allen LaPointe NM, Kramer JM, Califf RM. What clinicians should know about QT interval. JAMA 2003; 289: 2120-7.
7. Demolis J-L, Charransol A, Funck-Brentano C, Jaillon P. Effects of a single oral dose of sparfloxacin on ventricular repolarization in healthy volunteers. Br J Clin Pharmacol 1996; 41: 499-503.
8. Jaillon P, Morganroth J, Brumpt I, Talbot G, the Sparfloxacin Safety Group. Overview of electrocardiographic and cardiovascular safety data for sparfloxacin. J Antimicrob Chemother 1996; 37 (Suppl A): 161-7.
9. Therapeutic Research 1999; 20: 197-203.
10. Ball P. Quinolone-induced QT interval prolongation: a not-so-unexpected class effect. J Antimicrob Chemother 2000; 45: 557-9.
11. Shah RR. The significance of QT interval in drug development. Br J Clin Pharmacol 2002; 54: 188-202.
12. Noel GJ, Natarajan J, Chien S, Hunt TL, Goodman DB, Abels R. Effects of three fluoroquinolones on QT interval in healthy adults after single doses. Clin Pharmcol Ther 2003; 73: 292-303.
13. Katritsis D, Camm AJ. Quinolones: cardioprotective or cardiotoxic? PACE 2003; 26: 2317-20.
14. Amankwa K, Krishnan SC, Tisdale JE. Torsades de pointes associated with fluoroquinolones: Importance of concomitant risk factors. Clin Pharmcol Ther 2004; 75: 242-7.
15. Noel GJ, Goodman DB, Chien S, Solanki B, Padmanabhan M, Natarajan J. Measuring the effects of supratherapeutics doses of levofloxacin on healthy volunteers using four methods of QT correction and periodic and continuous ECG recordings. J Clin Pharmcol 2004; 44: 464-73.
16. Ansari SR, Chopra N. Gatifloxacin and prolonged QT interval. Am J Med Sci 2004; 327: 55-6.
17. Owens RC, Ambrose PG. Antimicrobial safety: focus on fluoroquinolones. CID 2005; 40: S456-69.
18. Patmore L, Fraser S, Mair D, Templeton A. Effects of sparfloxacin, grepafloxacin, moxifloxacin, and ciprofloxacin on cardiac action potential duration. European J Pharmacology 2000; 406: 449-52.
19. Frothingham R. Rates of torsades de points associated with ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin. Pharmacotherapy 2001; 21: 1468-72.
20. Morganroth J, Ilson BE, Shaddinger BC, Dabiri GA, Patel BR, Boyle DA, et al. Evaluation of vardenafil and sildenafil on cardiac repolarization. Am J Cardiol 2004; 93: 1378-83.
21. Choudhri S, Hollister A, Haverstock D, Jackson P, Church D. Evaluation of changes in QTc interval after intravenous infusion of moxifloxacin in hospitalized patients with community-aquired pneumonia. Int Pharm Abstr 2001; 36: 247.
22. Poloquin CA, Cumbo TJ, Nix DE, Sands MF, Schentag JJ. Evaluation of intravenous ciprofloxacin in patients with lower respiratory tract infections: Impact of plasma concentrations, organism, MIC, and clinical condition on bacterial eradication. Arch Intern Med 1989; 149: 2269-73.
23. Schentag JJ, Gilliland KK, Paladino JA. What have we learned from pharmacokinetic and pharmacodynamic theories?. Clinical Infections Diseases 2001; 32 (Suppl 1): S39-46.
24. Lode H, Borner K, Koeppe P. Pharmacodynamics of fluoroquinolones. Clinical Infections Diseases 1998; 27: 33-9.