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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT00838695
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 40 years, inclusive.
* Subject must be willing to give written informed consent and be able to adhere to diet and study schedules.
* Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
* Subjects must have a normal or clinically acceptable physical examination and ECG.
* Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator.
Exclusion Criteria:
* Any subject who has taken any prescription or over-the-counter drugs, other than oral contraception if female, within two weeks prior to study drug administration.
* Subjects who are presently, or were formerly, narcotic addicts or alcoholics.
* Subjects who have a clinically significant allergy/intolerance to phenylephrine.
* Females with a positive serum/urine pregnancy test at screening.
* Females who are nursing.
* Subject using sildenafil or other phosphodiesterase inhibitors.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00838695
Study Brief:
Protocol Section:
NCT00838695