[Comparative studies on the bioavailability of nicergoline from two different steady-state preparations].
Comparative Studies on the Bioavailability of Nicergoline from Two Different Preparations in Steady State The bioavailability of nicergoline (CAS 27848-84-6) in a new 30 mg tablet and a 10 mg dragee formulation (Sermion) was evaluated under steady state conditions in 18 healthy male volunteers between the age of 21 and 37 years. During the run-in phase, the volunteers received on 7 consecutive days 30 mg nicergoline either 1 x 30 mg/d tablet (test substance) or 3 x 10 mg dragees (reference). On day 8, after intake of 1 x 30 mg in a 24 h interval or 1 x 10 mg in a 8 h interval respectively, the plasma concentrations of the nicergoline metabolite 10-methoxy-6-methyl-ergoline-8 beta-methanol (MDL) were measured. The area under the plasma concentrations in the 24 h interval after administering the 30 mg tablet was not 3 times greater as to be expected; it was by a factor of 4 significantly greater than the area under the curve of the 10 mg dragee in the 8 h interval. Therefore, nicergoline has a higher availability in the 30 mg tablet than in the 10 mg dragee form. Both formulations were equally well tolerated.
Kohlenberg-Müller
K
K
Farmitalia Carlo Erba GmbH, Freiburg/Brsg.
Meier
D H
DH
Kunz
K
K
Wauschkuhn
C H
CH
Schaffler
K
K
D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D006801:Humans; D008297:Male; D009530:Nicergoline / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013607:Tablets
D013607:Tablets; D009530:Nicergoline
Vergleichende Untersuchungen zur Bioverfügbarkeit von Nicergolin aus zwei unterschiedlichen Darreichungsformen im Steady State.