[Bioequivalence of an optimized doxycycline preparation].
The galenically optimized and pharmaceutically balanced doxycycline preparation Sigadoxin was compared with a reference preparation according to the new "Criteria for testing of the bioavailability and bioequivalence of doxycycline-containing products" recommended by the Central Laboratory of German Pharmacists. The statistical evaluation of the AUC and Cmax of the trial preparations and the urinary excretion rates from commercial production batches, which were of good quality in accordance with the present state of pharmaceutical knowledge, showed the comparable bioavailability of the two preparations, which can thus be considered as bioequivalent. The AUC and Cmax for the trial preparation were 44.9 mg/l and 2.87 mg/l, respectively. For the reference preparation the values for these parameters were 50.3 mg/l and 3.19 mg/l, respectively. The relative bioavailability, based on the AUC, was 89.3%.
Lode
H
H
Medizinische Klinik und Poliklinik, Universitäts-Klinikum Steglitz, Freie Universität Berlin.
Deppermann
N
N
Schmidt
U
U
D000328:Adult; D001682:Biological Availability; D004318:Doxycycline / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D013810:Therapeutic Equivalency
D004318:Doxycycline
Bioäquivalenz einer optimierten Doxycyclin-Zubereitung.