Bioequivalence of a new atenolol formulation.
A new generic drug of atenolol, Atenolol (A), (Fahlberg-List Magdeburg, Germany) was studied in comparison with standard preparation (S) in their pharmacokinetic behaviour in 12 patients under steady state conditions. The concentration-time-profile of both preparations was nearly identical. The half time of elimination was calculated for A at 6.5 h and for S at 5.9 h. From the ratio of AUC from A to S (extent of absorption) a mean bioequivalence of 103.1% (90%-confidence limits 0.85-1.21) was estimated. Corresponding values for the rate of absorption were in the mean 102.8% (90%-confidence limits 0.94-1.12).
Rostock
G
G
Max Delbrück Center for Molecular Medicine, Berlin-Buch, Germany.
Vogel
I
I
Stulich
M
M
Günzel
R
R
D000328:Adult; D001262:Atenolol / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006207:Half-Life; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D013810:Therapeutic Equivalency
D001262:Atenolol