Bioequivalence study for diazepam commercial tablets in psychiatric patients.
The bioequivalence of three different commercial diazepam tablets (5 mg) using the innovator product (Valium, Roche) as a reference was evaluated in eight psychiatric patients, following a multiple-dose regimen (5 mg t.i.d.). Each patient received the four treatments sequentially according to a Latin square design, with balance for first residual effect. Blood samples were taken once the steady state of the drug had been reached, and the plasma levels were determined using a HPLC method. No statistical differences were found in diazepam steady-state levels after the administration of the four formulations, indicating that they could be considered equivalent.
Departamento Sistemas Biológicos, Universidad Autónoma Metropolitana-Xochimilco, México, D.F.
A
A
Domínguez
A
A
Cortés
H
H
Cárdenas
M C
MC
Galindo
J C
JC
Helgi
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001008:Anxiety Disorders / Q000188:drug therapy; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D003975:Diazepam / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008800:Mexico; D008875:Middle Aged; D013607:Tablets; D013810:Therapeutic Equivalency
D013607:Tablets; D003975:Diazepam