Pharmacokinetics of drospirenone and ethinylestradiol in Caucasian and Japanese women.
Eur J Contracept Reprod Health Care
; 17(4): 284-97, 2012 Aug.
Article
em En
| MEDLINE
| ID: mdl-22680989
ABSTRACT
OBJECTIVE:
To investigate the pharmacokinetics of drospirenone (DRSP) and ethinylestradiol (EE) in Caucasian and Japanese women.METHOD:
Three open-label, non-randomised studies were performed to assess the pharmacokinetics following single doses of EE 0.02 mg/DRSP 3 mg or DRSP monotherapy (1, 3 or 6 mg) in Caucasian (Study 1) and Japanese (Study 2) women, and daily doses with EE 0.02 mg/DRSP 3 mg over 21 consecutive days in Caucasian and Japanese women (Study 3).RESULTS:
In Studies 1 and 2, there was a linear dose-dependent increase in DRSP C(max) and systemic exposure across the range of doses used in both ethnic groups. The co- administration of EE had no relevant effect on the pharmacokinetic parameters of 3 mg DRSP. In Study 3, steady-state DRSP concentrations were achieved after about eight days of treatment in both ethnic groups with approximately a threefold accumulation. There was about a twofold EE accumulation over 21 days in both ethnic groups. There were no differences in DRSP or EE exposure at day 21 between ethnic groups; the ratio of the geometric means (Japanese/Caucasian) of the AUC(0-24h) were 1.05 (90% CI 0.95-1.17) and 1.02 (90% CI 0.76-1.38), respectively.CONCLUSION:
Ethnic origin had no clinically relevant influence on the pharmacokinetics of DRSP and EE.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Substâncias para o Controle da Reprodução
/
Povo Asiático
/
População Branca
/
Etinilestradiol
/
Androstenos
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Female
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Humans
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article