[A relative bioavailability study of 2 oral formulations of omeprazole after their administration in repeated doses to healthy volunteers].
To determine the relative bioavailability of Ulceral (study formula) with respect to Losec (reference standard formula) and establish their bioequivalence daily doses of 20 mg of omeprazole were given during 5 consecutive days to 24 healthy volunteers. No significant differences were observed in the area under the curve (AUC0-t), a parameter directly related to the inhibition of acid secretion induced by omeprazole. The confidence interval of 90% for the difference between the two formulations for AUC0-t was within the interval of acceptance (0.80-1.25). The confidence interval for the difference between the two formulations for Cmax were also within the range of acceptance (0.70-1.43). In relation to the time for achieving (Cmax (tmax), the difference between the two formulations and the confidence interval of 95% for the tmax was 0.75 (-0.5-1.75) h indicating that no significant differences were observed between the two treatments. This study confirms the bioequivalence of Ulceral with the standard reference formulation as well as the tolerability of the two formulae.
Richards
J P
JP
Drug Development (Escocia) Ltd., Ninewells Hospital and Medical School, Madrid.
Gimeno
M
M
Moreland
T A
TA
McEwen
J
J
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid / Q000706:statistics & numerical data; D016001:Confidence Intervals; D006801:Humans; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D012016:Reference Values; D012107:Research Design; D013997:Time Factors
D009853:Omeprazole