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This study evaluated the utility of combination of digoxin (0.25 mg) and rosuvastatin (5 mg) as a new transporter (P‐glycoprotein/breast cancer resistance protein/organic anion‐transporting polypeptide ( OATP )1B1/ OATP 1B3) probe cocktail (Oita combination) for drug–drug interaction ( DDI ) studies by demonstrating lack of  DDI  of digoxin on the pharmacokinetics ( PK s) of rosuvastatin, as it was already known that rosuvastatin did not affect digoxin  PK . This was an open‐label, two‐period study in which the primary end points were the geometric mean ratio ( GMR ) of the area under the plasma rosuvastatin concentration‐time curve from time zero to last ( AUC  last ) after rosuvastatin administration combined with digoxin to that after rosuvastatin administration alone and its 90% confidence interval ( CI ). As the  GMR  of  AUC  last  was 0.974 and its 90%  CI  was 0.911–1.042, it was judged that digoxin does not affect rosuvastatin  PK . Results of this study have rationalized utility of the Oita combination as a transporter probe cocktail for clinical  DDI  studies.

No Effect of Digoxin on Rosuvastatin Pharmacokinetics in Healthy Subjects: Utility of Oita Combination for Clinical Drug–Drug Interaction Study