Personal history of malignant neoplasm of breast
Conditions
Interventions
For the sample size calculation, the level of significance was set at 5%, the power of the test at 90% and the difference between the groups at 30%. Twenty premenopausal patients aged less than 50 yea
16 and 24 hours after administration of the daily dose of tamoxifen. To investigate the in vivo activities of CYP2D6, CYP3A and P-gp, patients received single oral doses of metoprolol 100 mg, midazola
0.50
5 and 6 hours after single dose administration. For fexofenadine, 10 blood samples were collected at the times: predose
8 and 12 hours after the single dose
Drug
Sponsors
Faculdade de Ciências Farmacêuticas de Ribeirão Preto
Faculdade de Ciências Farmacêuticas de Ribeirão Preto
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Breast cancer patients on adjuvant tamoxifen treatment for more than 80 days who have not been treated with other co-medications that may interfere with the study have been investigated. For the study, two groups of patients will be delimited according to age and hormonal status, being a premenopausal group (age less than 50 years) and another postmenopause (age higher than 60 years).
Exclusion criteria
Exclusion criteria: Patients with comorbidities that interfere with the metabolism of tamoxifen and the probe drugs were excluded; patients who have previously chemotherapy and / or target therapy; patients who have contraindications to the use of the probe drugs metoprolol, midazolam and fexofenadine; and psychiatric patients unable to understand ICF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference initially expected was 30% in plasma concentrations of tamoxifen and its metabolites among the premenopausal and postmenopausal groups employing a non-compartmental and population pharmacokinetic analysis.;At the end of the study, a greater than 40% difference in plasma concentrations of tamoxifen and its metabolites was found between the premenopausal and postmenopausal groups using a non-compartmental and population pharmacokinetic analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactJoão Paulo Ximenez
Faculdade de Ciências Farmacêuticas de Ribeirão Preto
Outcome results
None listed