Bioequivalence of tiopronin enteric capsules in healthy volunteers / 南方医科大学学报
Journal of Southern Medical University
;
(12): 1632-1634, 2009.
Article
Dans Chinois
| WPRIM
| ID: wpr-282629
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the bioequivalence of tiopronin enteric capsules (testing preparation, T) versus tablets (reference preparation, R).</p><p><b>METHODS</b>A single oral dose of tiopronin enteric capsules or tablets at 200 mg was administered in 2 groups of Chinese healthy volunteers (n=9) in a randomized crossover design at the interval of 2 weeks. The plasma concentrations of tiopronin were measured by HPLC-MS/MS, and the pharmacokinetic parameters were calculated by DAS 2.0 program. The bioequivalence between the two preparations was evaluated.</p><p><b>RESULTS</b>The main pharmacokinetic parameters were as follows C(max)(microg.ml(-1)) 3.612-/+1.2393 (R), 3.644-/+1.540 (T); t(max) 4.333-/+1.0853 (R), 3.611-/+1.420 (T); t((1/2))(h) 18.245-/+11.270 (R), 23.403-/+10.500 (T); AUC0-t (microg.h.ml(-1)) 18.732-/+6.92318 (R), 18.713-/+6.585 (T); AUC0-infinity (microg.h.ml(-1)) 21.900-/+7.31220 (R), 20.780-/+7.965 (T). The relative bioavailability of tiopronin enteric capsule was 103.712-/+23.956%, with 90% confidential intervals of ln(AUC0-->72), ln(AUC0-infinity) and ln(C(max)) of 91.1%-111.8%, 96.8%-118.3%, and 85.1%-113.0%, respectively.</p><p><b>CONCLUSION</b>The tiopronin enteric capsules were bioequivalent to the tablets.</p>
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Capsules
/
Pharmacocinétique
/
Biodisponibilité
/
Équivalence thérapeutique
/
Modèles linéaires
/
Santé
/
Reproductibilité des résultats
/
Études croisées
/
Tiopronine
Type d'étude:
Essai clinique contrôlé
/
Étude pronostique
Limites du sujet:
Humains
/
Mâle
langue:
Chinois
Texte intégral:
Journal of Southern Medical University
Année:
2009
Type:
Article
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