Aims To investigate dose proportionality, dosing frequency, and ethnic aspects of the pharmacokinetics of bambuterol in asthmatic children, and to discuss the relationship with previous observations in adults. Methods Forty-eight children in four different studies completed two double-blind bambuterol treatments each (daily doses of bambuterol hydrochloride): 12 preschool (5 mg×2 vs 10 mg ) and 12 school (10 mg vs 20 mg ) Caucasians, 12 preschool (2.5 mg vs 5 mg), and 12 school (10 mg vs 20 mg ) Orientals. Peak plasma concentrations and dosing interval area under curve (AUC) of bambuterol and the active metabolite terbutaline were assessed at steady state. Treatment differences were analysed statistically within each study. Differences between the studies and the relation to steady-state AUC in adults were described.
Objective. Proof of bioequivalence is important for the interchangeability of pharmaceutically equivalent drug products. This study aimed to compare the rate and extent of absorption of meloxicam 15 mg tablet of Pascual Laboratories, Inc. (Test) with meloxicam 15 mg tablet (Mobic) of Boehringer Ingelheim (Reference) in healthy Filipino men. In addition, the study also determined the safety and tolerability of single doses of the said medications, under the same conditions.Methods. This was a randomized, open label, blind-endpoint analysis, truncated, crossover study with single drug doses administered in the fasting condition in each of the two treatment periods, separated by a two-week washout period. Pharmacokinetic blood sampling was performed up to 72 h post-dose. Plasma samples were analyzed using a validated liquid chromatography with tandem mass spectrometry technology. The primary endpoints were: area under plasma-concentration-time curve from time zero to the last observed concentration at time 72 h (AUC 0-72 ) and maximum plasma concentration (C max ) for meloxicam.Results. Eighteen men (mean age 21.5 years; mean body mass index 22.9 kg/m 2 ) completed the study. When administered one meloxicam 15 mg tablet, the ratios of the geometric means of the primary endpoints AUC 0-72 and C max , were within the established bioequivalence limits of 80% to 125% compared with Mobic 15 mg tablet: 104.07% (90% Confidence Interval [CI]: 100.26, 108.03), and 103.34% (90% CI: 96.22, 110.97), respectively. No adverse event was reported. Conclusion.Meloxicam 15 mg tablet of Pascual Laboratories, Inc. and the innovator Mobic 15 mg tablet are bioequivalent. Single doses of both products were safe and well tolerated.
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