Comparative bioavailability and steady state fluctuations of Tegretol commercial and carbamazepine OROS tablets in adult and pediatric epileptic patients.
The comparative bioavailability and steady state fluctuations resulting from the administration of Tegretol 200 mg commercial tablets and carbamazepine OROS controlled delivery tablets were investigated in 22 adult and 12 pediatric epileptic patients. Tegretol commercial tablets were dosed according to previously established clinical regimens of 400 to 2000 mg daily doses divided into four equal or unequal intervals. Carbamazepine OROS was dosed every 12 h at the same corresponding daily dose. Comparisons of the pharmacokinetic parameters AUC, Cmax, Cmin, and tmax at steady state for the two dosage forms demonstrated definitively the bioequivalence of carbamazepine OROS with Tegretol commercial tablet over a 24-h treatment interval.
Thakker
K M
KM
Clinical Pharmacokinetics and Disposition, Drug Development Department, CIBA-GEIGY Corporation, Ardsley, New York 10502.
Mangat
S
S
Garnett
W R
WR
Levy
R H
RH
Kochak
G M
GM
D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002220:Carbamazepine / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D002648:Child; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D004827:Epilepsy / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
D003692:Delayed-Action Preparations; D002220:Carbamazepine