Evaluation of bioequivalence of sirolimus capsules in healthy Chinese male volunteers / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 296-299, 2012.
Article
in Chinese
| WPRIM
| ID: wpr-860820
ABSTRACT
OBJECTIVE:
To evaluate the bioequivalence of domestic sirolimus capsules and commercially available sirolimus oral solution in healthy Chinese volunteers.METHODS:
Twenty-two healthy Chinese male volunteers were enrolled and orally administered 5 mg sirolimus capsules or oral solution randomly. The concentrations of sirolimus in whole blood were determined by LC-MS/MS.RESULTS:
The pharmacokinetic parameters of sirolimus capsules and oral solution were as following ρmax(26.62 ± 9.97) and (25.28 ± 5.98) ng · mL-1; tmax(2.27 ± 0.55) and. (1.91 ± 2.33) h; t1/2 (73.07 ± 13.81) and (65.49 ± 17.00) h; AUC0-t (372.3 ± 146.2) and (368.2 ± 275.0) ng middot; h middot; mL-1, AUC0-∞ (466.8 ± 194.3) and (442.3 ± 324.4) ng middot; h middot; mL-1, respectively. The relative bioavailability F0-t was (112.4 ± 34.61)% and F0-∞ was (117.2 ± 39.93)%. Two-sided t-test of ρmax, AUC0-t and AUC0-∞ indicated that the preparations were equivalent, and non-parametric test showed that sirolimus capsules had larger tmax than the reference preparation with a significant difference (P < 0.05).CONCLUSION:
The domestic sirolimus capsule is bioequivalent to the marketed sirolimus oral solution with significantly different tmax. Copyright 2012 by the Chinese Pharmaceutical Association.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Pharmaceutical Journal
Year:
2012
Type:
Article
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