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An open, controlled, crossover study on the effects of cimetidine on the steady-state pharmacokinetics of trovafloxacin.
- Source :
-
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology [Eur J Clin Microbiol Infect Dis] 1998 Jun; Vol. 17 (6), pp. 431-3. - Publication Year :
- 1998
-
Abstract
- Twelve healthy male volunteers participated in this open, randomized, placebo-controlled, two-way crossover study to investigate the effects of cimetidine on the steady-state pharmacokinetics of oral trovafloxacin. Volunteers were randomized to receive either 400 mg cimetidine twice daily or placebo for 5 days. From day 3-5, volunteers received 200 mg trovafloxacin once daily in addition to either cimetidine or placebo. After a minimum 7-day washout period, the study was repeated: those volunteers who received placebo during the first study period were administered cimetidine, and vice versa. The maximum observed serum trovafloxacin concentration, the area under the concentration-time curve of trovafloxacin within the dosing interval of 24 h and the earliest time to the maximum serum concentration for trovafloxacin in volunteers receiving concomitant cimetidine were 2.4 microg/ml. 27.8 microg x h/ml and 1.4 h, respectively, compared with 2.5 microg/ml, 27.1 microg x h/ml and 1.5 h, respectively, in volunteers receiving concomitant placebo. Thus. multiple dosing with cimetidine had no significant effect on the absorption or disposition of trovafloxacin at steady state. Co-administration of cimetidine and trovafloxacin was also well tolerated and without serious adverse effects.
- Subjects :
- Administration, Oral
Adolescent
Adult
Analysis of Variance
Anti-Infective Agents administration & dosage
Anti-Infective Agents blood
Area Under Curve
Cimetidine administration & dosage
Cross-Over Studies
Drug Administration Schedule
Histamine H2 Antagonists administration & dosage
Humans
Male
Naphthyridines administration & dosage
Naphthyridines blood
Anti-Infective Agents pharmacokinetics
Cimetidine pharmacology
Fluoroquinolones
Histamine H2 Antagonists pharmacology
Naphthyridines pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 0934-9723
- Volume :
- 17
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
- Publication Type :
- Academic Journal
- Accession number :
- 9758288
- Full Text :
- https://doi.org/10.1007/BF01691578