Manufacturer’s PK data (inves­tigator’s brochure) [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2015-04-02 16:05 (3368 d 03:06 ago) – Posting: # 14657
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Hi Mittyri & Mauricio,

❝ I would suggest that it isn't high according to this article (there is a link to the internal data where bioequivalence was showed with 12 subjects only, although in the year 1992 :-D)


I don’t think that this was a BE-study at all. Smells of PK-modeling:

The pharmacokinetics of levocloperastine and racemic DL-cloperastine were comparable in a single-dose, crossover study in 12 healthy volunteers (six males and six females). After administration of 10 ml of oral suspension containing levocloperastine fendizoate 70.8 mg (corresponding to 40 mg of the chlorhydrate salt and 36 mg of the active prin­ciple) or the same amount of racemic levocloperastine, peak plasma concentrations of 10 μg/L were reached 2 to 4 hours after administration, with a lag-time of approximately 45 minutes before detection of the drug in the bloodstream, suggesting a gradual and pro­tracted absorption from the intestine. A two-compartmental model with absorption phase, corresponding to a tri-exponential concentration-time profile, best describes the pharmacokinetics of levocloperastine. The half-lives of levocloperastine and DL-clo­per­astine were, respectively, 0.80 and 0.86 h (distribution half-life), 1.68 and 2.16 h (eli­mi­nation half-life), and 6.58 and 6.95 h (terminal elimination half-life).

Their terminology is odd. I would rather say: 0.80/0.86 h (absorption t½), 1.68/2.16 h (dis­tri­bution t½), and 6.58/6.95 h (elimination t½).

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