Pharmacokinetic study of the interaction between natural equol supplement and hormone therapy drugs for breast cancer
Not Applicable
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCTs031200084
- Lead Sponsor
- Sambe Takehiko
- Brief Summary
EQUELLE had no clinically significant effect on the pharmacokinetics of tamoxifen, anastrozole, letrozole and exemestane in healthy postmenopausal women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
1. Postmenopausal women
2. Weight more than or equal to 40kg
3. Body mass index between 17.6 and 30.0 kg/m2
Exclusion Criteria
1. Breast cancer patients
2. Pregnant women
3. Lactating women
4. Having Soy allergy
5. History or presence of clinically significant neurologic, cranial nerve, cardiovascular, respiratory, hepatic, renal, endocrine or metabolic disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Impact of Equol supplement on exposure of hormone therapy drugs for breast cancer
- Secondary Outcome Measures
Name Time Method