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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT01354418
Eligibility Criteria:
Inclusion Criteria:
* In good health
* Female participants must not be pregnant
* Agrees to use two acceptable methods of birth control throughout the study
* Agrees not to take monoamine oxidase inhibitor (MAOI) for 2 weeks prior to, during, and 2 weeks after the end of the study
Exclusion Criteria:
* Any significant medical condition which is a contraindication to the use of phenylephrine HCl, might interfere with the study, or requires treatment expected to affect blood pressure
* Any infectious disease within 4 weeks prior to initial treatment administration
* History of malignancy, except basal cell carcinoma
* Cannot comply with requirement to abstain from the use of any drugs (except acetaminophen or herbal/vitamin supplements) within 14 days prior to study and alcohol or xanthine-containing substances (coffee, chocolate) within 72 hours prior to study
* Received an investigational drug within thirty days prior to study drug dosing
* Known or apparent current or former drug addicts or alcoholics
* Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B surface antigen, or hepatitis C antibody
* Cannot accept a high-fat, high-calorie breakfast
* Known allergy or intolerance to phenylephrine HCl
* Have used phenylephrine-containing product within 2 weeks prior to study start
* Have smoked tobacco, used tobacco products, or used a nicotine-containing smoking cessation aid within the past 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01354418
Study Brief:
Protocol Section:
NCT01354418