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  • 1
    Electronic Resource
    Electronic Resource
    Prolongation of the PQ interval as a measure of therapeutic inequivalence between two formulations of diltiazem (1995)
    Springer
    European journal of clinical pharmacology 48 (1995), S. 45-49 
    Details
    ISSN: 1432-1041
    Keywords: Diltiazem ; PQ interval ; ECG ; bioequivalence ; therapeutic equivalence
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract We studied the use of atrioventricular (AV) conduction time to assess the therapeutic equivalence of two diltiazem formulations in 20 volunteers in a double-blind, cross-over trial. ECG recording was carried out before and at several intervals after drug administration, and prolongation of the PQ interval (ΔPQ) was taken as a pharmacodynamic response. In addition, diltiazem plasma concentrations were determined in 8 subjects. The effect of diltiazem increased proportionally with the plasma concentration and could be detected up to 10 h after administration. The area under the effect-time curve (AUEC0–10), the peak effect (Emax), and the effect mean residence time (MRTE) showed significant differences. In contrast to the pharmacodynamics, the pharmacokinetic profiles of diltiazem do not vary to the same extent. We conclude that the formulations are therapeutically different. Furthermore, at the administered dose, ΔPQ appears to be a sensitive measure for assessing the electrophysiological properties of diltiazem.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00202171
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Effect of two different doses of nitrendipine on steady-state plasma digoxin level and systolic time intervals (1986)
    Springer
    European journal of clinical pharmacology 31 (1986), S. 391-395 
    Details
    ISSN: 1432-1041
    Keywords: nitrendipine ; digoxin ; plasma levels ; interaction ; systolic time intervals ; adverse effects ; healthy volunteers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The effect of two different doses of nitrendipine on plasma digoxin levels, urinary recovery and systolic time intervals was investigated in 8 healthy volunteers. Following a loading dose, digoxin 0.25 mg b.d. p.o. was given alone for 2 weeks. Then 0.25 mg digoxin b.d. was administered for two 1-week periods combined with nitrendipine 10 mg or 20 mg once daily. The study was completed with another digoxin monotherapy phase lasting 7 days. Nitrendipine 20 mg daily led to a significant increase in plasma digoxin levels and in its area under the plasma concentration-time curve AUC (0–12) compared to digoxin monotherapy. The AUC (0–12) was 9.7 ng ml−1h when digoxin alone was given and 11.2 ng ml−1h on co-administration of the calcium antagonist. Urinary recovery and renal clearance of digoxin were slightly but not significantly increased by nitrendipine. Nitrendipine 10 mg once daily caused a small, insignificant tendency to elevate the plasma digoxin level. Nitrendipine co-administration (10 and 20 mg once daily) did not significantly alter systolic time intervals, as non-invasively measured haemodynamic parameters, compared to digoxin treatment alone. Thus, nitrendipine 20 mg daily caused a significant increase in plasma digoxin concentrations and in its AUC, which would rarely be of clinical relevance.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00613512
    Library Location Call Number Volume/Issue/Year Availability
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    Paper (German National Licenses)
    Fulltext
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