Comparative pharmacokinetics of different oral nifedipine preparations in healthy Brazilian volunteers.
1. The pharmacokinetics of different pharmaceutical preparations of oral nifedipine--Adalat (capsule), Oxcord and Cardalin (tablets)--was determined after administration of single oral doses of 10 mg to nine healthy young Brazilian volunteers (7 men). 2. There were no significant changes in heart rate or systolic and diastolic blood pressure measured in the sitting position within 8 h of nifedipine administration to these normotensive volunteers. No side effects were reported by the volunteers or observed by the attending physicians during the study. 3. No significant differences were observed among the three preparations in relation to the following pharmacokinetic parameters obtained from the plasma concentration-time curves: area under the curve (AUC), slope (beta) and half-life (T1/2) of the elimination phase, volume of distribution (Vd/F) and total body clearance (CL/F), both expressed as functions of the oral bioavailability (F) of nifedipine. 4. The peak plasma concentration of nifedipine (Cmax) and the time to reach Cmax (Tmax) were not different for the two tablet preparations. However, Cmax was significantly higher, and Tmax was significantly shorter for the capsule. These data indicate that the capsule and the tablet preparations are not bioequivalent.
Vianna-Jorge
R
R
Departamento de Farmacologia Básica e Clínica, Universidade Federal do Rio de Janeiro, Brasil.
Sudo
R T
RT
Melo
P A
PA
Suarez-Kurtz
G
G
D000284:Administration, Oral; D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D001938:Brazil; D004304:Dosage Forms; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D009543:Nifedipine / Q000493:pharmacokinetics* / Q000494:pharmacology
D004304:Dosage Forms; D009543:Nifedipine