[Relative bioavailability of an optimised galenical formulation of mefloquine].
The bioequivalence of an optimised formulation of a generic mefloquine (Mephaquin Lactabs/Test) compared to the reference product under fed conditions was assessed in a GCP/ICH conformable study. A standard two-way randomised crossover design with a 9 week washout period between treatments was used. Blood samples for determination of mefloquine concentrations for calculation of Cmax and AUC were collected at pre-dose and at predefined intervals up to 2016 hours after administration of a single oral dose of 750 mg. A standard bioequivalence analysis was performed on the two one-sided t-test procedure for log-transformed Cmax and AUC. 90% confidence intervals were calculated for both parameters and evaluated against regulatory standards of 80-125% (T/R). Analysis of plasma for mefloquine concentration was performed using a validated LC/MS method with MS detection. The ratio of mean AUC and Cmax (T/R) was 1.015 and 1.044, respectively. The 90% confidence intervals were 95.8-109.3% for AUC and 98.2-110.5% for Cmax. Mephaquin produces plasma concentrations comparable to those after administration of the reference product. The 90% confidence intervals for AUC and Cmax are within the acceptable ranges for bioequivalence of 80-125%. Thus, the optimised galenical formulation of Mephaquin Lactabs is bioequivalent to the reference product.
Kovács
P
P
Universitäitklinik Debrecen, Ungarn.
Edwards
D
D
Stoeckel
K
K
Scheiwe
M W
MW
Cambon
N
N
Heidecker
J L
JL
D000284:Administration, Oral; D000328:Adult; D000962:Antimalarials / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D001682:Biological Availability; D016001:Confidence Intervals; D018592:Cross-Over Studies; D016568:Drugs, Generic / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D015767:Mefloquine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D008962:Models, Theoretical; D013810:Therapeutic Equivalency; D013997:Time Factors
D000962:Antimalarials; D016568:Drugs, Generic; D015767:Mefloquine