Lack of effect of eprosartan on the single dose pharmacokinetics of orally administered digoxin in healthy male volunteers

Br J Clin Pharmacol. 1997 Jun;43(6):661-4. doi: 10.1046/j.1365-2125.1997.00608.x.

Abstract

Aims: To study the effect of eprosartan, a nonbiphenyl tetrazole angiotensin II receptor antagonist, on digoxin pharmacokinetics in a randomized, open-label, two period, period balanced crossover study in 12 healthy men.

Methods: Each subject received a single 0.6 mg oral dose of digoxin (Lanoxicaps 0.2 mg/capsule, Glaxo Wellcome) alone or following 4 days of dosing with eprosartan 200 mg orally every 12 h. Each study period was separated by a 14 day washout interval. Serial blood samples were obtained for up to 96 h after each digoxin dose for determination of digoxin pharmacokinetics. The effect of eprosartan on digoxin pharmacokinetics was assessed through an equivalence-type approach using AUC(0, t') as the primary endpoint.

Results: For AUC(0, t'), the ratio of digoxin+eprosartan: digoxin alone was 0.99 with a 90% confidence interval (CI) of [0.90, 1.09]. For Cmax, the ratio was 1.00 with a 90% CI of [0.86, 1.17]. tmax was similar for both regimens. Both regimens were safe and well tolerated.

Conclusions: Based on AUC and Cmax data, it can be concluded that eprosartan has no effect on the pharmacokinetics of a single oral dose of digoxin.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acrylates / administration & dosage
  • Acrylates / pharmacology*
  • Administration, Oral
  • Adult
  • Anti-Arrhythmia Agents / administration & dosage
  • Anti-Arrhythmia Agents / pharmacokinetics*
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / blood
  • Antihypertensive Agents / pharmacology*
  • Area Under Curve
  • Cross-Over Studies
  • Digoxin / administration & dosage
  • Digoxin / blood
  • Digoxin / pharmacokinetics*
  • Drug Interactions
  • Humans
  • Imidazoles / administration & dosage
  • Imidazoles / pharmacology*
  • Iodine Radioisotopes
  • Isotope Labeling
  • Male
  • Radioimmunoassay
  • Receptors, Angiotensin / drug effects
  • Receptors, Angiotensin / metabolism
  • Thiophenes*

Substances

  • Acrylates
  • Anti-Arrhythmia Agents
  • Antihypertensive Agents
  • Imidazoles
  • Iodine Radioisotopes
  • Receptors, Angiotensin
  • Thiophenes
  • eprosartan
  • Digoxin