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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00709267
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Nonpregnant
* Nonlactating
* Nonsmoking women
* With a history of regular menstrual cycles
* Weighing at least 110 pounds
* Having a body mass index between 18 and 28 kg/m2
* And having a hematocrit of at least 36%
Exclusion Criteria:
* Known history of vitamin B-12 deficiency or a current need for vitamin B-12 injections
* Elevated blood pressure (BP) (i.e., sitting systolic BP \>140 mm mercury \[Hg\] and/or diastolic BP \>90 mm Hg)
* Had tested positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV)
* Recent history (within 12 months prior to the first admission visit) of alcohol or other substance abuse or tested positive for drugs of abuse, such as amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and tricyclic antidepressant agents
* Used barbiturates, antiepileptics, rifampin, griseofulvin, St. John's Wort or other hepatic enzyme inducing drugs within 30 days before randomization
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00709267
Study Brief:
Protocol Section:
NCT00709267