Safety and Pharmacokinetic Study of BIO 300 Capsules

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for use starting at 500 mg.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Humanetics Corporation
• Collaborator: United States Department of Defense

Criteria

Inclusion Criteria:

• Healthy male and female subjects, age 18-64, who have signed the consent form

• Subjects with a body mass index (BMI) 18-30 kg/m2

• Subjects who are willing to abstain from sex or use a barrier method of birth control (Women 1 week, Men 4 months after leaving the trial)

• Subjects with a negative pregnancy test and drug screen

• Subjects with laboratory values within normal limits (CBC/differential, CMP, enzymes, ECG, vital signs, urinalysis)

• Subjects with ability to comprehend and complete the questionnaires and forms

• Subjects who are likely to comply with study procedures and test article consumption

• Subjects whose schedules permit a 10-12 hour stay in the clinic followed by daily evaluations for one week (7 days)

• Subjects who are available for a 14-day follow up phone call (women) and 4-month follow up phone call (men).

• Subjects who are likely to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial

• Subjects who are likely to follow the low isoflavone diet program

Exclusion Criteria:

• · Subjects with any allergic reaction or sensitivity to soy, isoflavones, or any component of the test article product

• Subjects who consume >5 alcoholic beverages per week

• Subjects who are pregnant, lactating, or at risk of becoming pregnant

• Subjects who have blood (or urine) levels outside the normal range for any of the hepatic, renal, hematologic, lipid or coagulation parameters measured.

• Subjects on Hormone Replacement Therapy or Birth Control Pills within the past three months.

• Subjects on any other clinical trial or experimental treatment in the past 3 months

• Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, uncontrolled hypertension, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.