Comparative biopharmaceutical performance of imipramine formulations in man

Journal of Clinical Pharmacology
M A GagnonR Dugal


The systemic availability of an investigational liquid formulation of imipramine was compared to that of a commercially available tablet (Tofranil) whose therapeutic efficacy has been established by usage. The experiment was conducted under controlled conditions and a balanced 2-by-2 crossover design was used to dissociate the significance of formulation effects from subject, group, and experimental period sources of variation. Pharmacokinetic interpretation and statistical analysis of plasma concentrations as a function of time and of systemic availability indicators reveal a nearly identical biopharmaceutical behavior for the two preparations. Significant differences (P less than 0.05) were found in the cumulative area under the plasma concentration--time curve (AUC) up to 4 hours after administration and the availability lag time, but not in the maximum plasma concentration, the time at which this concentration is reached, the first-order availability rate constant, and the AUC to infinity. These results collectively indicate a very similar biopharmaceutical performance, where the differences in the early AUC values are partly attributable to a longer availability lag time for the tablet formulation.


Jul 1, 1976·Journal of Pharmaceutical Sciences·A J Sedman, J G Wagner
Nov 15, 1977·Psychopharmacology·N ReisbyJ Christiansen
Mar 1, 1976·Clinical Pharmacology and Therapeutics·L F GramJ Christiansen
Feb 1, 1977·Archives of General Psychiatry·A H GlassmanJ L Fleiss
Sep 24, 1975·Naunyn-Schmiedeberg's Archives of Pharmacology·A Nagy, R Johansson
May 1, 1975·Clinical Pharmacology and Therapeutics·L F Gram, J Christiansen
May 1, 1976·Clinical Pharmacology and Therapeutics·H DenckerA Nagy
Jan 1, 1968·Psychopharmacologia·J L CrammerB Rolfe

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Nov 11, 2003·Clinical Pharmacokinetics·David R P Guay

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