AIM: To compare the pharmacokinetic profiles and dose proportionality of olanzapine in Chinese and Caucasian subjects. METHODS: Randomized, three-period study with 12 Chinese and 12 Caucasian, healthy, male subjects administered 2.5, 5 and 10 mgolanzapine. Noncompartmental pharmacokinetic parameters were derived. RESULTS: No statistically significant racial differences in the weight-normalized pharmacokinetic parameters were observed except for Vz/Fnorm, which was 17% lower at the 5- and 10-mg dose in the Chinese group (95% confidence interval 8.49, 10.1 and 8.05, 9.73, respectively), compared with the Caucasian group (9.53, 12.8 and 9.39, 12.0, respectively). Olanzapine's pharmacokinetics were linear and dose proportional in both racial groups. CONCLUSION: The pharmacokinetics of olanzapine are similar in both Chinese and Caucasian racial groups.
RCT Entities:
AIM: To compare the pharmacokinetic profiles and dose proportionality of olanzapine in Chinese and Caucasian subjects. METHODS: Randomized, three-period study with 12 Chinese and 12 Caucasian, healthy, male subjects administered 2.5, 5 and 10 mg olanzapine. Noncompartmental pharmacokinetic parameters were derived. RESULTS: No statistically significant racial differences in the weight-normalized pharmacokinetic parameters were observed except for Vz/Fnorm, which was 17% lower at the 5- and 10-mg dose in the Chinese group (95% confidence interval 8.49, 10.1 and 8.05, 9.73, respectively), compared with the Caucasian group (9.53, 12.8 and 9.39, 12.0, respectively). Olanzapine's pharmacokinetics were linear and dose proportional in both racial groups. CONCLUSION: The pharmacokinetics of olanzapine are similar in both Chinese and Caucasian racial groups.
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