Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2008
Randomized Controlled Trial Comparative StudyLong-term effect of the beta2-receptor agonist procaterol on daily life performance and exercise capacity in patients with stable chronic obstructive pulmonary disease. Clinical study with special reference to health-related quality of life and activities of daily living.
The present study was undertaken to evaluate the long-term effect of procaterol hydrochloride (CAS 62929-91-3, Meptin), a third generation beta2-receptor agonist on lung function, exercise capacity, health-related quality of life (HRQOL) and activities of daily living (ALDs) in patients with stable chronic obstructive pulmonary disease (COPD). Twenty patients were randomly assigned to the procaterol group or to the control group, who received oxitropium bromide (CAS 30286-75-0), an anticholinergic agent. Procaterol was inhaled three times a day at a dose of 20 pg, while oxitropium was inhaled three times a day at a dose of 200 microg. ⋯ Additionally, 6-min walking distances and Borg Scale values showed significant improvement at 12, 24 and 52 weeks compared with baseline values in the procaterol group (p < 0.05, p < 0.01), but did not significantly differ from baseline values in the oxitropium group at any point (p > 0.05). Likewise, the scores for dyspnea, fatigue, emotional function, mastery, total scores and ADLs were significantly higher at 12, 24 and 52 weeks compared with the baseline values in the procaterol group (p < 0.05, p < 0.01), but did not differ at any point in the oxitropium group (p > 0.05). These results suggest the effectiveness of long-term regular bronchodilator therapy with the beta2-receptor agonist procaterol in patients with stable COPD.
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Arzneimittel Forsch · Jan 2008
Comparative StudyBioequivalence study of two capsule formulations containing diacerein 50 mg in healthy human subjects.
This study presents the results of a two-way, two-period, two-treatment crossover investigation in 12 healthy Indian male subjects to assess the bioequivalence of two oral formulations containing 50 mg of diacerein (CAS 13739-02-1). Both formulations were administered orally as a single dose separated by a one-week washout period. The content of diacerein in plasma was determined by a validated HPLC method with UV detection. ⋯ The results of this study indicated that there were no statistically significant differences between the logarithmically transformed AUC(0-infinity) and Cmax, values of the two preparations. The 90% confidence interval for the ratio of the logarithmically transformed AUC(0-t), AUC(0-infinity) and Cmax were within the bioequivalence limit of 0.8-1.25 and the relative bioavailability of the test formulation was 96.63% of that of the reference formulation. Thus, these findings clearly indicate that the two formulations are bioequivalent in terms of rate and extent of drug absorption.