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 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT02491606
Eligibility Criteria:
Inclusion Criteria:
1. Healthy subjects (male or female)
2. Age of 18-55 years
3. Residing in one of the study villages of the Nyanza Province for the entire study
Exclusion Criteria:
1. Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
2. Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
3. Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
4. Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
5. Known hypersensitivity to any study drug.
6. Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
7. Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02491606
Study Brief:
Protocol Section:
NCT02491606