In an open-labelled cross-over study, ten healthy males received an oral dose of piretanide (6 mg tablet), penbutolol (40 mg film-coated tablet) or the fixed dose combination (film-coated tablet). Serum pharmacokinetics and 48 h urinary excretion of each drug were determined for the three dose regimens. The serum pharmacokinetics and excretion of penbutolol were unchanged in combination with piretanide. In combination with penbutolol the maximum serum concentration (Cmax) of piretanide was lowered by 40% (p less than 0.05) and time to reach Cmax delayed from 1.0 h to 1.6 h (p less than 0.05). However, areas under the serum concentration-time curves over 12 h and excretion of piretanide were unchanged, and its diuretic effect was undiminished. Thus the bioavailability of piretanide was unaffected by combination with penbutolol. The above changes in the pharmacokinetics of piretanide were explained entirely by differences in dissolution of the conventional and film-coated tablets. The drugs were safe and well tolerated.
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