Pharmacokinetics and relative bioavailability of prajmalium bitartrate after single oral dosing.
Pharmacokinetics and relative bioavailability of the marketed prajmalium bitartrate tablet (Neo-Gilurytmal, CAS 2589-47-1) compared to an oral solution were investigated in an open, randomized, single-dose two-fold crossover study in 20 healthy male volunteers. One subject was identified to be a poor metabolizer. In the study population with normal metabolic status the two oral formulations proved to be bioequivalent with regard to the pharmacokinetic parameters Cmax, AUC(0-Tlast), AUC(0-infinity) and Ae(24h). tmax was prolonged after administration of the tablets. The relative bioavailability of prajmalium bitartrate from the tablet amounted to 112%. The poor metabolizer demonstrated in both oral formulations high plasma concentrations, increased AUCs and prolonged terminal half-lives as well as increased renal excretion of prajmalium bitartrate.
Breuel
H P
HP
AFB Klinische Pharmakologie GmbH, Berlin, Fed. Rep. of Germany.
Weimann
H J
HJ
Dahmen
W
W
Hausleiter
H J
HJ
Bondy
S
S
D000328:Adult; D001682:Biological Availability; D006207:Half-Life; D006801:Humans; D008297:Male; D011219:Prajmaline / Q000493:pharmacokinetics*; D012996:Solutions; D013607:Tablets
D012996:Solutions; D013607:Tablets; D011219:Prajmaline