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Titolo:
CLINICAL PHARMACOLOGICAL EQUIVALENCE OF A NOVEL FCH FREE GTN SPRAY WITH LOW ETHANOL CONTENT VS A FCH CONTAINING GTN SPRAY
Autore:
DEMEY C; ERB K; ZIMMERMANN T; MUTSCHLER H; BLUME H; BELZ GG;
Indirizzi:
BOEHRINGER INGELHEIM KG,ZENTRUM HUMAN PHARMAKOL D-55216 INGELHEIM GERMANY POHL BOSKAMP GMBH & CO D-25551 HOHENLOCKSTEDT GERMANY ZENT LAB DEUTSCHER APOTHEKER D-65760 ESCHBORN GERMANY CTR CARDIOVASC PHARMACOL D-65189 WIESBADEN GERMANY
Titolo Testata:
European Journal of Clinical Pharmacology
fascicolo: 5, volume: 47, anno: 1995,
pagine: 437 - 443
SICI:
0031-6970(1995)47:5<437:CPEOAN>2.0.ZU;2-X
Fonte:
ISI
Lingua:
ENG
Soggetto:
GLYCERYL TRINITRATE; DIGITAL PLETHYSMOGRAPHY; NITRATES; BIOEQUIVALENCE; NITROGLYCERIN; PHARMACOKINETICS; BIOAVAILABILITY;
Keywords:
NITROGLYCERIN; GLYCERYL TRINITRATE; FLUOROCHLOROHYDROCARBONS; BIOEQUIVALENCE, DIGITAL PLETHYSMOGRAPHY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
46
Recensione:
Indirizzi per estratti:
Citazione:
C. Demey et al., "CLINICAL PHARMACOLOGICAL EQUIVALENCE OF A NOVEL FCH FREE GTN SPRAY WITH LOW ETHANOL CONTENT VS A FCH CONTAINING GTN SPRAY", European Journal of Clinical Pharmacology, 47(5), 1995, pp. 437-443

Abstract

The overall therapeutic equivalence of a fluorochlorohydrocarbon (FCH)-free glyceryl trinitrate (GTN) pump spray with a low ethanol content(TL) was investigated relative to an FCH-containing GTN spray (Nitrolingual; R), in terms of: (1) pharmacokinetic bioavailability, (2) pharmacodynamic responses as assessed by digital plethysmography (DPG), and (3) clinical perception upon application. Pharmacokinetically, the time courses of the plasma concentrations of GTN and its dinitrate metabolites, 1.2- and 1.3-GDN, subsequent to the sublingual administrationof 0.8 mg GTN showed somewhat lower bioavailability of GTN and its metabolites than to the reference. Pharmacodynamically, the changes in the DPG signals after the application of 0.8 mg GTN with TL were biostatistically euivalent with R (estimated ratio TL/R for the maximum decrease of the ratio between the systolic a wave and c incisure: 0.98; 90% CI: 0.84-1.14; and for the average decrease of the c: a ratio: 0.97; 90 % CI: 0.80-1.16). The time of occurrence of the maximum effect ofTL was not significantly different from that of R (estimated difference TL-R: -2.25 min; 95 % CI: -9.5 min to 2 min). In contrast. after the administration of an FCH-free GTN spray with a higher ethanol content (TH, active control), the effect had a slightly earlier onset (TH R:-6 min, 95 % CI: -9.5 to -2 min) and there was a higher average response (TH/R: 1.12: 90 % CI: 0.95 to 1.34). However, TH was consistently judged to cause an extremely unpleasant burning sensation in the mouthand thus was perceived as distinctly different from R. In contrast, TL was well tolerated and could not be distinguished from R. Therefore only TL met the criteria of overall therapeutic equivalence to R.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 19/09/20 alle ore 15:23:11