Bioequivalence of two fexofenadine formulations in healthy human volunteers after single oral administration.
OBJECTIVE
A randomized, two-way, crossover, bioequivalence study was conducted in 25 fasting, healthy, male volunteers to compare two brands of fexofenadine 180 mg tablets, FEXOFENADINE 180 mg Film Tablet (Drogsan A.S., Ankara, Turkey) as test and Telfast 180 mg Tablet (Aventis Pharma, Frankfurt am Main, Germany) as a reference product.


METHODS
One tablet of either formulation was administered after 10 h of overnight fasting. After dosing, serial blood samples were collected during a period of 48 hours. Plasma samples were analysed for fexofenadine by a validated HPLC method. The pharmacokinetic parameters AUC(0-48), AUC(0-alpha), C(max), T(max), K(el), T(1/2), and CL were determined from plasma concentration-time profiles for both formulations and were compared statistically.


CONCLUSIONS
The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range, satisfying the bioequivalence criteria of the FDA. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetics profiles and that Drogsan's Fexofenadine is equivalent to Telfast of Aventis Pharma, Frankfurt am Main, Germany.
Mendoza
Luis
L
I.Q.A., a.s., Prague, Czech Republic. mendoza@iqa.cz
Begany
Pavel
P
Dyrhonova
Marketa
M
Emritte
Nizam
N
Svobodova
Xenia
X
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013607:Tablets; D016593:Terfenadine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D013810:Therapeutic Equivalency
D018926:Anti-Allergic Agents; D039563:Histamine H1 Antagonists, Non-Sedating; D013607:Tablets; D016593:Terfenadine; C093230:fexofenadine