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Lack of effect of eprosartan on the single dose pharmacokinetics of orally administered digoxin in healthy male volunteers
Author(s) -
Martin D. E.,
Tompson D.,
Boike S. C.,
Tenero D.,
Ilson B.,
Citerone D.,
Jorkasky D. K.
Publication year - 1997
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.1997.00608.x
Subject(s) - digoxin , pharmacokinetics , medicine , pharmacology , crossover study , oral administration , dosing , placebo , heart failure , alternative medicine , pathology
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 C max , the ratio was 1.00 with a 90% CI of [0.86, 1.17]. t max was similar for both regimens. Both regimens were safe and well tolerated. Conclusions Based on AUC and C max data, it can be concluded that eprosartan has no effect on the pharmacokinetics of a single oral dose of digoxin.