Healthy human volunteers soy isoflavones,
Conditions
Interventions
Soy and ciprofloxacin preparation: The soy preparation used in this study is the UHT soy beverage (V-
soy®,
manufactured by Green Spot Co,
Bankok,
Thailand). The ciprofloxacin used is CIPROBAY® (ciprofloxacin HCL) oral tablet 250 mg (manufactured by Bayer Healthcare Pharmaceuticals Inc.,
Germany).
Experimental Drug
soy beverage and ciprofloxacin
Sponsors
Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
Female
Age
46 Years to No maximum
Inclusion criteria
Inclusion criteria: Aged >45 years with postmenopausal status >1 years and serum follicle-stimulating hormone (FSH) concentration >40 IU/L, the body mass index (BMI) must be within 18-25 kg/m2. Subjects are in good health based on medical history and physical examination.
Exclusion criteria
Exclusion criteria: Subjects with abnormal hematological diseases or impaired kidney or liver function. Subjects with known contraindication or hypersensitivity to soy isoflavones or ciprofloxacin will be excluded as well as those with history of malignancy, cardiovascular, pulmonary, or breast disease. History of musculoskeletal diseases such as arthralgia or back pain, joint stiffness, achiness, neck or chest pain, and flare up of gout. Other exclusion criteria include a history of cigarette smoking, substance abuse or addiction, regular consumption of alcohol-containing beverages, and use of antibiotics and laxative within the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: Cmax, Tmax, AUC, terminal half-life (t1/2) before dosing, and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, and 32 hours after oral administration of the Plasma/High-Performance Liquid Chromatography (HPLC) methods | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A N/A N/A | — |
Countries
Thailand
Contacts
Public ContactAssoc. Prof. Supanimit Teekachunhatean
Faculty of Medicine, Chiang Mai University
Outcome results
None listed