Drug-drug interaction study between a novel oral ibandronate formulation and metformin

in Drug Research (formerly Arzneimittelforschung); 61, 12; 707-713; Drug Research (formerly Arzneimittelforschung)
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Abstract

The novel excipient, sodium N-[8-(2-hy-droxybenzoyl)amino]caprylate (SNAC, CAS 203787-91-1) increases the oral bioavailability of co-formulated ibandronate (IBN, CAS 138926-19). The aim of this study was to investigate the effect of the IBN/SNAC formulation on the steady-state pharmacokinetics of metformin (CAS 657-24-9) and to assess safety and tolerability of IBN/SNAC when dosed in combination with metformin. Twenty-two healthy subjects received metformin on Days 1 to 6. On Day 7, subjects received metformin together with the IBN/ SNAC formulation. The safety and tolerability of IBN/SNAC co-administered with metformin was consistent with the known safety profile of the single medications. The increase in mean maximum plasma concentration (Cmax) and mean overall exposure to metformin (AUC0–τ) was approximately 7%. The entire 90% confidence intervals for the AUC- and Cmax-ratios did fall within the acceptance region for bioequivalence (0.8-1.25). In summary, administration of the IBN/ SNAC formulation together with metformin did not lead to a significant increase in exposure to metformin. The study medication was well tolerated in healthy volunteers.


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