The pharmacokinetics and bioavailability of domperidone, a novel gastrokinetic, were studied in healthy male subjects by comparing plasma concentrations and urinary excretion following intravenous, intramuscular, oral and rectal administration. Two oral dosage forms were studied: 10-mg tablets and a 10-mg/ml oral solution. The influence of a meal on the oral bioavailability and the dose-proportionality were also investigated. Plasma levels of intravenous domperidone could be described by a three-compartment model with a rapid distribution of 40% of the dose to a "shallow" peripheral compartment. The final elimination half-life was 7.5 hours. Peak plasma levels were reached within 30 minutes following intramuscular and oral administration and at 1-4 hours following rectal administration. Since domperidone showed an extensive first-pass elimination, AUC-values -a measure for the bioavailability- were considerably lower after oral than after parenteral administration. Equal oral and rectal doses gave a similar bioavailability. AUC-values increased proportionally with the dose over a 10-60 mg range. Cumulative urinary excretion of unchanged domperidone was proportional to corresponding AUC-values. The bioavailability was discussed in the light of the therapeutic results.
In a double-blind study, 117 non-pregnant women with vaginal candidosis were treated for 3 days with 200 mg-tablets of ketoconazole taken once, twice or three times daily. The incidence of predisposing factors or of a recurrence history did not differ between treatment groups. Their male partners were randomly assigned to receive ketoconazole, 200 mg twice daily or placebo for 3 consecutive days. Cure and recurrence rates were not different in the three treatment groups, with or without simultaneous treatment of the male partner. Treatment of the sexual partner in the three dose-regimengroups proved not to have influenced the therapeutic effect. 14, 537-540.
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