𝔖 Bobbio Scriptorium
✦   LIBER   ✦

RELATIVE BIOAVAILABILITY OF FOUR CLOMIPRAMINE HYDROCHLORIDE TABLET PRODUCTS

✍ Scribed by F. O. Müller; R. Schall; E. M. Mogilnicka; G. Groenewoud; H. K. L. Hundt; H. G. Luus; M. V. Middle; K. J. Swart; A. C. De Vaal

Publisher
John Wiley and Sons
Year
1996
Tongue
English
Weight
419 KB
Volume
17
Category
Article
ISSN
0142-2782

No coin nor oath required. For personal study only.

✦ Synopsis

The relative bioavailability of clomipramine was determined in two single-blind, singledose, randomized, crossover studies. In the first study, the relative bioavailability of the test product, 2 x 25mg clomipramine hydrochloride tablets (Noristan Ltd.), with respect to the reference product, AnafranilB 2 x 25 mg tablets (clomipramine HCl; Ciba-Geigy (Pty) Ltd.) was determined. In the second study, the relative bioavailability of the test product, 5 x lOmg clomipramine hydrochloride tablets (Noristan Ltd.), with respect to the reference product, Anafranita 5 x 10 mg tablets (clomipramine HCI; Ciba-Geigy (Pty) Ltd.), was determined.

The geometric mean values for the variable C,, were 31.3 ngmL-I for the reference and 31.6ngmL-L for the test product in study 1. The geometric mean values for the variable AUC were 736nghmL-' and 753nghmL-' for the reference and test, respectively. In study 2, the geometric mean C , , values were 25+3ngmL-' and 23.9 ngmL-' for the reference and test respectively; the geometric mean AUC values were 569 ng h mL-' and 547 ng hmL-I.

The 90% confidence intervals for the 'test/reference' mean ratios of the plasma clomipramine pharmacokinetic variables C,, and AUC[&,) (as measures of the rate and extent of absorption of clomipramine, respectively) fall within the conventional bioequivalence range of 8&125% for both studies. The test products (clomipramine HC1) are therefore bioequivalent to the reference products (AnafranilB) with respect to the rate and the extent of absorption of clomipramine in both lOmg and 25mg strengths.

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