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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT00200759
Eligibility Criteria:
Inclusion Criteria:
* Females must have a negative urine pregnancy test prior to enrollment and must be committed to using barrier methods of birth control throughout the study.
Exclusion Criteria:
* Clinically significant diseases or abnormal laboratory values as assessed during the screening medical history, physical exam, and laboratory evaluations.
* A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease. The exclusion criteria also includes 1) positive urine pregnancy test 2) The use of oral contraceptives 3) The lack of use of acceptable barrier methods of birth control unless abstinent
* Use of any concomitant medication including herbal medications or a history of hypersensitivity to the medications used in the study
* History of sensitivity to CB juice or products
* Poor metabolizers of CYP2D6
* Active smoking or use of caffeine-containing beverages for 2 weeks prior to and during the study
* Inability to conform with dietary restrictions required for the study
* Drug or alcohol abuse (more than 3 drinks/day)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00200759
Study Brief:
Protocol Section:
NCT00200759