Bioequivalence evaluation of two oral formulations of quetiapine fumarate in healthy volunteers.
One bioequivalence study was carried out in healthy volunteers in order to compare the rate and extent of absorption of two oral formulations of quetiapine fumarate (CAS 111974-72-2) 25 mg film-coated tablet. Thirty subjects were administered quetiapine fumarate film-coated tablet of test and reference formulation in an open-label, randomised, fasting, two-period, two-sequence, crossover study. Blood samples were taken before and within 48 h after drug administration. Plasma concentrations were determined by LC/MS/MS. Log-transformed AUC and Cmax values were tested for bioequivalence based on the ratios of the geometric means (test/reference). Tmax was analysed nonparametrically. The 90% confidence intervals of the geometric mean values for the test/reference ratios for AUCo-t, and Cmax were within the bioequivalence acceptance range of 80-125%. It may be therefore concluded that the test formulation of quetiapine fumarate 25 mg film-coated tablet is bioequivalent to the reference product and can be prescribed interchangeably.
Laboratorios Lesvi, S.L. - Invent Farma Group, Sant Joan Despí, Barcelona, Spain. mcanovas@lesvi.com
Mercedes
M
Cánovas
Ferran
F
Torres
Gema
G
Domenech
Jesús
J
Cebrecos
Pilar
P
Pelagio
Gemma
G
Martínez
Francisco
F
Polonio
Francesc
F
Cabré
D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003987:Dibenzothiazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D013058:Mass Spectrometry; D000069348:Quetiapine Fumarate; D018401:Sample Size; D013608:Tablets, Enteric-Coated; D013810:Therapeutic Equivalency; D055815:Young Adult
D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D013608:Tablets, Enteric-Coated; D000069348:Quetiapine Fumarate