[A model study of bioequivalence of dissolved nifedipine from soft gelatin capsules]. 1988

G Menke, and M Kausch, and N Rietbrock
Abteilung für Klinische Pharmakologie des Klinikums der Johann Wolfgang Goethe-Universität, Frankfurt/Main.

Oral absorption of nifedipine determined from plasma concentrations was studied in 20 healthy subjects aged 19 to 40 years following application of a single soft gelatin capsule as a generic preparation (P) and a reference preparation (R) containing 10 mg nifedipine. Nifedipine was measurable in plasma 15 min after application and maximal concentrations occurred after 0.44 and 0.64 h (mean), respectively. Maximal concentrations Cmax varied between 46.4 and 251.0 ng/ml (median 100.7, mean 112.6) after P and between 35.5 and 279.7 ng.h/ml (median 115.8, mean 125.2) after R. Mean areas under the curves (AUC0-infinity) were 173.6 (median 151.4 P) and 188.6 ng.h/ml (median 163.1, R). The minor differences in the AUC values and Cmax values were not statistically significant. The shorter tmax after the generic preparation (p less than 0.05) is clinically unimportant. Since the bioavailability of P is 97% the two preparations are bioequivalent.

UI MeSH Term Description Entries
D008297 Male Males
D009543 Nifedipine A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure. Adalat,BAY-a-1040,Bay-1040,Cordipin,Cordipine,Corinfar,Fenigidin,Korinfar,Nifangin,Nifedipine Monohydrochloride,Nifedipine-GTIS,Procardia,Procardia XL,Vascard,BAY a 1040,BAYa1040,Bay 1040,Bay1040,Monohydrochloride, Nifedipine,Nifedipine GTIS
D002214 Capsules Hard or soft soluble containers used for the oral administration of medicine. Capsule,Microcapsule,Microcapsules
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies

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