Pharmacokinetics and tolerance of a new fluoroquinolone antimicrobial drug after single oral doses in healthy volunteers

Xenobiotica. 1995 Nov;25(10):1119-25. doi: 10.3109/00498259509061912.

Abstract

1. The pharmacokinetics and tolerance of DV-7751a were investigated in healthy male Caucasian volunteers after single oral doses (100, 200, 400 and 800 mg). 2. DV-7751a was rapidly absorbed in the fasted state. The mean maximum concentration in plasma (Cmax) ranged from 0.27 to 1.98 micrograms/ml for the 100-800-mg dose and the mean time to reach Cmax (tmax) ranged from 1.1 to 1.9 h. The terminal half-life ranged from 8.75 to 10.0 h. A good linear correlation (r = 0.974) was found between doses from 100 to 800 mg and the resulting area under the concentration-time curve (AUC). The plasma protein binding of the drug was in the range of 57-65%. 3. Within 48 h, the cumulative urinary excretion of unchanged drug amounted to 22.0-26.8% of the dose administered. Faecal recovery of the drug up to 72 h after the 400-mg dose was about 12% of the dose given. 4. Adverse events thought to be possibly related to the drug included headache, rash, leg cramp, diarrhoea, abdominal pain, CNS depression and dizziness. DV-7751a, however, was well tolerated with no serious adverse events at any doses and all subjects completed the study. No drug crystals were observed in the urine.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anti-Infective Agents / adverse effects*
  • Anti-Infective Agents / pharmacokinetics*
  • Blood Proteins / metabolism
  • Chromatography, High Pressure Liquid
  • Cross-Over Studies
  • Double-Blind Method
  • Feces / chemistry
  • Fluoroquinolones*
  • Humans
  • Intestinal Absorption
  • Male
  • Protein Binding
  • Quinolones / adverse effects*
  • Quinolones / pharmacokinetics*

Substances

  • Anti-Infective Agents
  • Blood Proteins
  • Fluoroquinolones
  • Quinolones
  • DV 7751a