[Bioequivalence of non-retard verapamil. Realization of a draft monograph exemplified by Veramex 80].
The commercial preparation Veramex 80, containing 80 mg non-retarded Verapamil, was compared to the appropriate product being first on the market and containing the same amount of active substance according to the AMG 1976. This study was a randomized single-dose trial with a double cross-over-design and a one-week wash-out phase between the individual test periods. Equivalence of the most relevant pharmacokinetic parameters was checked in 18 volunteers according to the latest recommendations and regulations of the Zentrallaboratorium Deutscher Apotheker (ZL) and the APV-guidelines. The mean AUC (0-24) after application of Veramex 80, calculated with 217.2 micrograms X h/l +/- 65.6, was approximately 10% less than the mean AUC (0-24) after application of the reference substance, which reached 240.4 micrograms X h/l +/- 87.0. The difference was statistically not significant and the 90%-confidence interval could be estimated with 0.82 to 1.01 which is in accordance with the postulated limits (0.8 to 1.2). After application of the reference drug the mean maximal concentration (cmax) of Verapamil was 58.1 micrograms/l and thus approximately 10% higher than the appropriate value detected after application of Veramex 80, which was 51.8 micrograms/l. Again, this difference was statistically not significant and the 90%-confidence interval, calculated with 0.76 to 1.05, was located within the postulated limits (0.7 to 1.3). Mean value, median and the range for tmax after application of Veramex 80 resp. reference substance were comparable and differences were less than 30 minutes.(ABSTRACT TRUNCATED AT 250 WORDS)
Klinische Forschung, Sanofi Pharma GmbH, München.
M
M
Gierend
J P
JP
Baarsma
W W
WW
Floris
D000284:Administration, Oral; D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D013810:Therapeutic Equivalency; D014700:Verapamil / Q000008:administration & dosage* / Q000493:pharmacokinetics
D014700:Verapamil
Untersuchung zur Bioäquivalenz von nichtretardiertem Verapamil. Umsetzung eines Monographieentwurfs am Beispiel Veramex 80.