Expired Study
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Chapel Hill, North Carolina 27599


Purpose:

A series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and botanicals are known to rely upon or to modulate, respectively, metabolism via glucuronidation.


Study summary:

As per Brief Summary


Criteria:

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.


NCT ID:

NCT00065741


Primary Contact:

Principal Investigator
Philip C Smith, PhD
School of Pharmacy, UNC Chapel Hill


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27599
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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