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:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
NCT ID:
NCT03145012
Eligibility Criteria:
Inclusion Criteria:
* Age 20-50 years old, all sexes or genders
* Veins acceptable for blood draw
* Able to provide informed consent
* eGFR \> 90 mL/min/1.73m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG, urinalysis). Clinical laboratory values within stated normal range; if not within this range, they must be without clinical significance
* Female volunteers who are of childbearing potential that agree to use of the accepted contraceptive regimens from at least 21 days prior to the first administration of study drug, during the study, and for at least 30 days after the last dose of study drug
* Female volunteers who are postmenopausal (no menses for at least 1 year, or surgically sterile
Exclusion Criteria:
* Use of ranitidine for greater than 1 week within 6 months of starting the study
* Medical requirement for ranitidine use
* Current or past diagnosis of: porphyria, cancer, immune deficiency disorder
* Active infection at the time of screening
* Known liver, hematologic, renal disease
* Past history of allergic reaction to ranitidine or past history of hypersensitivity to any ingredient in the formulation or past history of hypersensitivity to other drugs
* Pregnant, planning to be pregnant, or breastfeeding during the study period
* Weight (kg) exceeds 109kg
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT03145012
Study Brief:
Protocol Section:
NCT03145012