[Bioequivalence of nifedipine sustained-release formulations in comparison to standard preparations in solid state].
The bioavailability of a nifedipine extended release capsule-formulation (CAS 21829-25-4, Aprical retard) was investigated in comparison to a standard retard tablet. The design of the study was two-way cross-over with 24 male volunteers in the steady state after 4 days saturation with doses of 20 mg nifedipine b.i.d. The relative bioavailability of the test preparation amounted to 98.5% for AUCSS and 82.7% for Cmax with respect to the standard preparation. Statistical test procedures decide on equivalence. Typical characteristics for extended release preparations as peak-trough fluctuation (%PTF) and half-value duration (HVD50%) resulted in quotients of 67.3% and 145.1%, respectively. These data indicate the well balanced retardation of nifedipine in the test preparation.
Herrmann
R
R
Abteilung Qualitätssicherung/Biopharmazie, Dr. Rentschler Arzneimittel GmbH & Co., Laupheim.
D000328:Adult; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D006207:Half-Life; D006801:Humans; D008297:Male; D009543:Nifedipine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D009543:Nifedipine