Bioequivalence study of a valsartan tablet and a capsule formulation after single dosing in healthy volunteers using a replicated crossover design.
OBJECTIVE
Two formulations of valsartan (Diovan), 320 mg tablets and marketed 160 mg capsules, were evaluated for bioequivalence after single dosing.


METHODS
The study was designed as a single-center, open-label, 2-treatment, 3-period, repeated-measure (replicated), randomized crossover comparison in 40 healthy volunteers, all of whom completed the study successfully. Valsartan was determined in plasma by HPLC with fluorescence detection after solid-phase extraction.


RESULTS
Comparing the new 320 mg tablet with 2 x 160 mg of the marketed valsartan capsules taken at the same time, the ratios of the least square means for AUC(0-t), AUC(all), AUC(0-infinity) and Cmax were 1.11, 1.10, 1.10 and 1.09, respectively. The 90% confidence intervals of the AUC and Cmax parameters were within the range of 0.80-1.25.


CONCLUSIONS
Bioequivalence of the new 320 mg tablet with 2 marketed 160 mg capsules was demonstrated.
Séchaud
R
R
Novartis Pharma AG, Basel, Switzerland. romain.sechaud@pharma.novartis.com
Graf
P
P
Bigler
H
H
Gruendl
E
E
Letzkus
M
M
Merz
M
M
D000328:Adult; D019540:Area Under Curve; D002214:Capsules; D018592:Cross-Over Studies; D004304:Dosage Forms; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D008875:Middle Aged; D013607:Tablets; D013777:Tetrazoles / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D014633:Valine / Q000008:administration & dosage* / Q000031:analogs & derivatives / Q000097:blood / Q000493:pharmacokinetics*; D000068756:Valsartan
D002214:Capsules; D004304:Dosage Forms; D013607:Tablets; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine