Pharmacokinetics and bioequivalence of domestic olanzapine tablets in healthy Chinese volunteers
- Author:
Ling-Yan YU
1
Author Information
1. The 2nd Affiliated Hospital
- Publication Type:Journal Article
- Keywords:
Bioequivalence;
LC-MS/MS;
Olanzapine
- From:
Chinese Pharmaceutical Journal
2012;47(23):1934-1936
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To study the pharmacokinetics and bioequivalence of domestic olanzapine tablets in healthy Chinese volunteers. METHODS: A single oral dose of 5 mg olanzapine tablets was given to 20 healthy male volunteers in a randomized cross-over study. The concentrations of olanzapine in plasma were determined by LC-MS/MS method. The pharmacokinetic parameters and relative bioavailability were calculated by DAS. Then the bioequivalence of two formulations was evaluated. RESULTS: The pharmacokinetic parameters of domestic and imported formulations were as follows: tmax (4.25 ± 1.33) and (4.55 ± 1.10) h, ρmax (9.62 ± 1.79) and (9.69 ± 2.18) ng · mL-1, t1/2 (31.71 ± 6.87) and (32.46 ± 5.67) h, AUC0-t, (327.19 ± 60.55) and (324.39 ± 70.84) ng · h · mL-1, and AUC0-∞(354.44 ± 74.58) and (350.70 ± 80.94) ng · h · mL-1, respectively. The relative bioavailability was (102.93 ± 18.22)% for F0-t (and (103.30 ± 20.75)% for F0-∞. There was no significant difference between the two preparations (P > 0.05). CONCLUSION: The two preparations are bioequivalent and can be prescribed interchangeably.
