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Comparative bioavailability of a cisapride suppository and tablet formulation in healthy volunteers (1990)

Hedner, T. ; Hedner, J. ; Gelin-Friberg, A. ; [et al.]

Springer

European journal of clinical pharmacology 38 (1990), S. 629-631

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ISSN: 1432-1041

Keywords: Cisapride ; pharmacokinetics ; bioavailability ; suppository ; tablet

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Summary The comparative bioavailability of cisapride as a 30 mg suppository and three 5 mg oral tablets was investigated in 12 non-smoking, healthy male volunteers. The two formulations were administered on two separate occasions following an overnight fast, according to a randomized cross-over design. The plasma concentration of cisapride was measured over 48 h after drug administration. The 30 mg suppository exhibited a mean time to the peak plasma concentration of 3.8 h, while the tablets showed a significantly earlier peak time of 1.5 h. The maximum plasma concentration of cisapride after the 30 mg suppository (50.3 ng · ml−1) was significantly lower than after the tablets (74.3 ng · ml−1). The AUCs following the two treatments did not differ significantly from each other. The comparative bioavailability of the 30 mg cisapride suppository in relation to the three 5 mg oral tablets was 85%, with a 95%-confidence interval of 67% to 102% (not adjusted for dose). Normalizing the mean AUC by dose, the relative bioavailability of the suppository was 43% of that of the tablet. The elimination half-life of cisapride was not significantly different following the administration of the two formulations (9.3 h for the suppository and 9.8 h for the tablet).

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00278595

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The use and limitations of deuterated lorcainide in metabolism and pharmacokinetic studies (1985)

Gelijkens, C. F. ; Van Peer, A. ; Lenoir, H. ; [et al.]

Chichester : Wiley-Blackwell

Biological Mass Spectrometry 12 (1985), S. 38-42

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ISSN: 1052-9306

Keywords: Chemistry ; Analytical Chemistry and Spectroscopy

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Chemistry and Pharmacology

Notes: Lorcainide, a new antiarrhythmic agent currently undergoing clinical trial, has been pentadeuterated and the usefulness of this labelled compound in pharmacokinetic and metabolism studies has been investigated in dogs. Specific analytical methods based on capillary gas chromatography/mass spectrometry (GC/MS) were developed for quantitative and qualitative analysis of plasma and urine samples. Following oral administration of an equimolar mixture of 5:5 mg of (2H0/2H5)lorcainide, eight major metabolites were rapidly identifified in urine by the ion cluster technique. Quantitative analysis of (2H0/2H5)lorcainide in plasma and urine indicated an enhanced systematic availability of the deuterated compound, probably due to a secondary isotope effect. According to these findings in the dog, the use of deuterated lorcainide in human bioavailability and metabolism studies is probably of limited value.

Additional Material: 3 Ill.