19989
document
Comparative bioavailability of two formulations of terbinafine . Data from a cross-over , randomised , open-label bioequivalence study in healthy volunteers . An open-label , randomised , cross-over single dose study , using 2 periods x 2 sequences , with a minimum washout period of 21 days , was conducted in order to assess the comparative bioavailability of two formulations of terbinafine ( CAS 78628-80-5 ) 250 mg tablets . Plasma samples were obtained at baseline , +0.333 ; 0.667 ; 1.00 ; 1.33 ; 1.67 ; 2.00 ; 2.33 ; 2.67 ; 3.00 ; 3.50 ; 4.00 ; 6.00 ; 8.00 ; 12.0 ; 24.0 ; 36.0 ; 48.0 and 72.0 h post-administration . Terbinafine levels were determined by high pressure liquid chromatography with tandem mass detection ( HPLC-MS/MS ) and the lower limit of quantification was set at 9.99 ng/mL . The pharmacokinetic parameters used for the bioequivalence assessment ( AUClast , AUCinf and Cmax ) were determined from the terbinafine concentration data using non-compartmental analysis . Classical 90 % confidence intervals ( 90CI ) were calculated for the overall sample , and for males and females separately , and gender effects were investigated using an appropriate model . The results showed that overall classical 90CI were 96.08-105.40 % for AUCinf , 95.68-105.33 for AUClast and 88.24-112.83 for Cmax , that is , all within the predefined ranges for bioequivalence acceptance . Separate gender analysis showed very similar results for males and females when analysed independently , and no gender effects were detected ( p > 0.05 for all of the tested model effects ) . It may be therefore concluded that the evaluated formulations are bioequivalent in terms of rate and extent of absorption .
19990
Intervention_Pharmacological
terbinafine
19991
Intervention_Pharmacological
terbinafine ( CAS 78628-80-5 )
19992
Intervention_Pharmacological
Terbinafine
19993
Outcome_Physical
Comparative bioavailability
19994
Outcome_Physical
comparative bioavailability
19995
Outcome_Physical
Plasma samples
19996
Outcome_Physical
Terbinafine levels
19997
Outcome_Physical
high pressure liquid chromatography
19998
Outcome_Other
pharmacokinetic parameters
19999
Outcome_Mental
bioequivalence assessment ( AUClast , AUCinf and Cmax )
20000
Outcome_Other
Classical 90 % confidence intervals ( 90CI )
20001
Participant_Condition
healthy
20002
Participant_Sex
males
20003
Participant_Sex
females
20004
Participant_Sex
males
20005
Participant_Sex
females