Bioequivalence of tiopronin enteric capsules in healthy volunteers.
- Author:
Chong-yuan XU
1
;
Lin YANG
;
Wen-yan TANG
;
Yi XIANG
;
Zhen-yu QIAN
;
Jin YUAN
;
Bin-bin YANG
;
Heng ZHENG
Author Information
- Publication Type:Journal Article
- MeSH: Biological Availability; Capsules; Cross-Over Studies; Health; Humans; Linear Models; Male; Reproducibility of Results; Therapeutic Equivalency; Tiopronin; pharmacokinetics; Young Adult
- From: Journal of Southern Medical University 2009;29(8):1632-1634
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo evaluate the bioequivalence of tiopronin enteric capsules (testing preparation, T) versus tablets (reference preparation, R).
METHODSA 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.
RESULTSThe 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.
CONCLUSIONThe tiopronin enteric capsules were bioequivalent to the tablets.
