[The bioequivalence of two nifedipine fluid capsules].
Bioequivalence of Two Nifedipine Liquid Capsules Plasma concentration-time profiles of nifedipine were determined in an open, randomised cross-over study on 12 healthy volunteers after application of 10 mg nifedipine as two different soft gelatin capsule preparations. In vitro dissolution tests showed a significant difference between the reference preparation (R) and the generic preparation (P). Maximal nifedipine plasma concentrations (Cmax) measured at tmax (0.6 h, median) for P averaged 87.5 +/- 32.7 micrograms/l, corresponding values for R were 95.4 +/- 41.1 micrograms/l and 0.46 h. Differences in Cmax and tmax values were not statistically significant. Mean areas under the curves AUC(0-10 h) were 128.7 +/- 59.9 micrograms.h/h after p and 123.3 +/- 49.3 micrograms.h/l after R (n.s.). 95% confidence intervals for indices of bioavailability based on AUC and Cmax overlapped, indicating that the two preparations are bioequivalent.
Thürmann
P
P
Abteilung für Klinische Pharmacokologie am Klinikum, Johann Wolfgang Goethe-Universität, Frankfurt/Main.
Bacracheva
N
N
D000328:Adult; D002214:Capsules; D006801:Humans; D009543:Nifedipine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D002214:Capsules; D009543:Nifedipine
Zur Bioäquivalenz von zwei Nifedipin-Flüssigkapseln.