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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT01125904
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 75 years, inclusive.
* Subjects must be trained sensory panelists.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures.
Exclusion Criteria:
* A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history.
* A history of hypersensitivity to any inactive ingredients employed in the formulation(s).
* Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study.
* Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API.
* Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01125904
Study Brief:
Protocol Section:
NCT01125904