Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT00006395
Eligibility Criteria:
Male or female.
Healthy by medical history and physical exam.
Age between 21 and 65 years old.
Non-smoker for a minimum of 6 months.
AST/SGOT less than or equal to 2 x upper limit of normal.
Serum creatinine less than or equal to upper limit of normal.
Hemoglobin greater than or equal to 10 g/dl.
Females of childbearing potential must be using a reliable form of birth control other than hormonal contraceptives.
No concomitant therapy with other inhibitors or inducers of cytochrome P-450 mediated drug metabolism within 30 days of study.
No inability to remain free of chronic medications and alcohol for at least 2 weeks prior to and during the study.
No previous use of St. John's Wort. Subjects with prior history of St. John's Wort use must abstain from use for 30 days prior to study participation.
No presence of renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric, or respiratory disease or any other condition that may interfere with the interpretation of the study results or not be in the best interests of the subject in the opinion of the investigator.
No positive urine pregnancy test.
No presence of persistent diarrhea or malabsorption that would interfere with the patients ability to adequately absorb drugs.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT00006395
Study Brief:
Protocol Section:
NCT00006395