[Evaluation of the relative biological availability of amiodarone Polfa preparation after extravascular administration of a single dose].
Relative bioavailability of amiodarone was studied in 10 healthy volunteers after its 600 mg single dose administration. Mean values of individual maximal concentrations and time for reaching them did not significantly differ and were respectively 0.828 +/- 0.401 microgram/ml and 4.4 +/- 1.5 h for Amiodarone preparation Polfa and 0.541 +/- 0.207 microgram/ml and 5.2 +/- 1.6 h for Cordarone preparation. Bioavailability extent (EBA) of examined preparation was 120 per cent in comparison with the standard one. Amiodarone absorption from both preparations was slow and individually diversified. Absorption rate constant Ka did not statistically significant differ and was respectively 0.35 +/- 0.10 1/h and 0.49 +/- 0.35 1/h. Obtained data indicated that both preparations were biologically equivalent.
Paczkowski
D
D
Sadowski
Z
Z
Koliński
P
P
Filipek
M
M
Podleśny
J
J
D000284:Administration, Oral; D000328:Adult; D000638:Amiodarone / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D001682:Biological Availability; D004353:Drug Evaluation, Preclinical; D006207:Half-Life; D006801:Humans; D008297:Male; D008875:Middle Aged; D011044:Poland; D015022:Yugoslavia
D000638:Amiodarone
Ocena wzglednej dostepności biologicznej amiodaronu z preparatu amiodarone Polfa po jednorazowym podaniu pozanaczyniowym u ludzi.