Effect of NXY-059, a novel neuroprotectant, on the pharmacokinetics of a single dose of digoxin in healthy subjects
| Autor: | Gunilla Huledal, Olof Borgå, Mischa van Hout, Ingalill Reinholdsson, Matts Kågedal, Hanna Svensson, Dag Nilsson, Yi‑Fang Cheng |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Digoxin Adolescent Urine Pharmacology Placebo Mass Spectrometry Pharmacokinetics Humans Medicine cardiovascular diseases business.industry Benzenesulfonates Outcome measures Healthy subjects General Medicine Middle Aged Confidence interval Neuroprotective Agents Anesthesia Renal physiology Female business Anti-Arrhythmia Agents Chromatography Liquid medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 23:1531-1539 |
| ISSN: | 1473-4877 0300-7995 |
| DOI: | 10.1185/030079907x199646 |
| Popis: | NXY-059 is a novel free-radical trapping neuroprotectant. Digoxin treatment is common in acute ischaemic stroke, the intended patient population for NXY-059. Since both digoxin and NXY-059 are eliminated primarily renally, with a substantial contribution by active renal secretion, and because digoxin has a narrow therapeutic window, this open, randomised, crossover, two-period study investigated whether NXY-059 affects the pharmacokinetics (PK) of digoxin.Twenty-two healthy subjects received 0.5 mg oral digoxin 2 h after the start of 60-h intravenous infusions of NXY-059 and placebo separated by a 14-day washout. Blood and urine were collected for 60 h. Digoxin concentrations were measured by a novel liquid chromatography-mass spectrometry assay.The ratio of the geometric mean (90% confidence interval) between NXY-059 and placebo for the digoxin area under the concentration-versus-time curve was 0.91 (0.83-0.99) and was within the predefined range for no interaction (0.80-1.25). No safety concerns were raised in the study. No serious adverse events were recorded. The most common adverse event was headache with similar frequencies in the two treatments.NXY-059 had no clinically significant effect on the PK of digoxin. |
| Databáze: | OpenAIRE |
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