Comparative bioavailability of two oral formulations of bromazepam in healthy volunteers.
The aim of this study was to assess the pharmacokinetic profile of two bromazepam (CAS 1812-30-2) formulations in 24 healthy volunteers. An open, randomised clinical trial designed as two-period crossover with 14-day washout between doses was employed. Plasma samples for assessments of their bromazepam concentration by HPLC-UV were obtained over 96 h after administration. No adverse effect was reported for any of the formulations administered. The following pharmacokinetics parameters were calculated: AUC(0-96 h), AUCinf, Cmax, Tmax, Ke and T1/2. The 90% confidence intervals (CI) for the mean test/reference individual ratios were 81-109 for AUC and 84-116 for Cmax. Since the 90% CI for both, AUC and Cmax ratios were within the 80-125% interval proposed by the Food and Drug Administration, it is concluded that the new bromazepam slow-release formulation is therapeutic equivalent to the conventional formulation for both, the extent and the rate of absorption after single dose administration in healthy volunteers.
Lerner
F E
FE
ClinPhaseOne Group, EDyABE (Estudios de Diseño y Análisis BioEstadísticos), Contract Research Organisation, Buenos Aires, Argentina.
Schere
D
D
Batafarano
N
N
Casas
F
F
Glancszpigel
R
R
D000293:Adolescent; D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D001960:Bromazepam / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D011786:Quality Control; D013056:Spectrophotometry, Ultraviolet
D014151:Anti-Anxiety Agents; D003692:Delayed-Action Preparations; D001960:Bromazepam