Comparison of the pharmacokinetics of fosfluconazole and fluconazole after single intravenous administration of fosfluconazole in healthy Japanese and Caucasian volunteers.

Objectives: To investigate the bioavailability of fluconazole (FLCZ) from fosfluconazole (phosphate pro-drug of FLCZ) and to compare the pharmacokinetics of fosfluconazole and FLCZ in Japanese and Caucasian subjects.

Methods: In a randomised, double-blind, double-dummy, single-dose, two-period, crossover study, 12 Japanese and 12 Caucasian healthy subjects received a bolus intravenous injection of 1000 mg fosfluconazole or an intravenous infusion of 800 mg FLCZ in random order. Concentrations of fosfluconazole and FLCZ were determined in plasma and urine samples taken up to 144 h and 48 h post-dose, respectively.

Important effect of food on the bioavailability of oral testosterone undecanoate.

Study Objective: To assess the effects of food on the bioavailability of testosterone undecanoate, testosterone, and 5alpha-dihydrotestosterone (DHT) after administration of a new oral testosterone undecanoate formulation, Andriol Testocaps.

Design: Randomized, open-label, crossover study with a 1-week washout period.

Setting: Clinical pharmacology unit.

Galantamine pharmacokinetics, safety, and tolerability profiles are similar in healthy Caucasian and Japanese subjects.

The aim of this study was to compare the pharmacokinetics of galantamine in healthy Japanese and Caucasian subjects and assess the safety and tolerability of galantamine in both ethnic groups. Parallel groups of healthy Japanese (n = 13; 6 males and 7 females)and Caucasian (n = 12; 6 males and 6 females) subjects matched for weight and age received single oral doses of galantamine 4 mg, or galantamine 8 mg, or placebo in a double-blind, three-way crossover trial according to a randomized dosing schedule. Concentrations of galantamine and norgalantamine were determined in plasma and urine samples taken up to 48 and 24 hours after dosing, respectively.

Successful balloon valvuloplasty in an adult patient with severe pulmonic stenosis and aneurysmal poststenotic dilatation.

We present a case of pulmonic stenosis with large aneurysmal poststenotic dilatation that was safely and effectively treated with balloon valvuloplasty. Though the poststenotic dilatation persists after the procedure, the risk of dissection and rupture is very low. Hence, balloon valvuloplasty should be considered the treatment of choice in this setting.

The pharmacokinetics of pranlukast in healthy young and elderly subjects.

Pranlukast is a novel LTD4 antagonist under development for the treatment of asthma. To assess the effect of age, the pharmacokinetics of pranlukast were studied in healthy young (9 females, 10 males, mean 30 years) and elderly subjects (9 per sex, mean 70.4 years).