Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

Exclusion Criteria

• •History of any chronic, subacute or acute condition of clinical significance
• •Total bilirubin level \>0.9, conjugated bilirubin \>0.4, or unconjugated bilirubin \>0.8
• •Fasting cholesterol level \>280 mg/dL; fasting triglyceride level \>1.5 x ULN
• •History of thromboembolic events or estrogen-dependent benign or malignant neoplasm
• •Resting systolic blood pressure \>140 mm Hg or \<90 mm Hg, or diastolic blood pressure \>90 mm Hg or \<60 mm Hg
• •Resting pulse \>100 beats/minute or \<45 beats/minute
• •Abnormal 12-lead ECG or telemetry results
• •Subject is unwilling or unable to comply with study rules
• •History of sudden cardiac death in the immediate family, or a personal history of cardiac disease, treated hypertension, congestive heart failure, or unexplained syncope
• •History of cancer, other than basal cell carcinoma or stage 1 squamous cell carcinoma, that has not been successfully treated
• •Use of any prescription or over-the-counter medication within 1 week prior to Day -1 or anticipates the need for any medication during the course of the study
• •History or intolerance to estrogen medication
• •History of substance abuse, drug addiction, or alcoholism within 3 years
• •Inability to abstain from alcohol, caffeine, Yerba mate tea, or from grapefruit, grapefruit juice or flavonoid-rich foods from 48 hours prior to the administration of study medication and throughout the duration of the study.
• •History of smoking or any use of a tobacco or nicotine containing product within 6 months
• •Donated blood or blood products within 30 days
• •Mental instability or inability to be compliant with the protocol
• •Subject has received an investigational test substance within 60 days or anticipates receiving any investigational test substance other than S-equol during the course of this study
• •Subject has been previously enrolled in this study