Botanical/Drug Interactions in HIV: Glucuronidation

As per Brief Summary

Inclusion criteria

• Absence of HIV-1 infections

• Body mass index less than or equal to 30 kg/m2 and weigh at least 50 kg.
• Laboratory values obtained within 7 days of study entry within normal range for healthy volunteers.
• Able to be compliant with dosing schedules and diary record keeping.
• Able to follow dietary restrictions associated with the protocol.
• Ability and willingness to provide informed consent
• All women of reproductive potential must have a negative pregnancy test
• All women of reproductive potential to use contraception methods as defined by protocol
• All study subjects (male and female) must agree to not participate in a conception process

Exclusion criteria

• History of any acute or chronic illness that requires current medical therapy including active gastrointestinal conditions that might interfere with drug absorption.
• History of hepatic, renal, cardiovascular, gastrointestinal diseases.
• Current gastrointestinal disturbance.
• Receipt of any prescribed or over the counter medication or ingested CAM during the 30 days prior to study entry except: Over the counter acetaminophen or ibuprofen at doses not exceeding package labeling guidelines.
• Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
• Pregnancy or breastfeeding.
• Allergy/sensitivity to study agent(s) or their formulations.
• Active drug or alcohol abuse or dependence, which in the opinion of the investigator would interfere with adherence to study requirements or would endanger the subject's health while on study.
• Before entering the study, subjects must agree not to consume alcohol for 48 hours prior to PK sampling days.
• Participation in any investigational drug studies within 30 days prior to study entry and during study.