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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02488902
Eligibility Criteria:
Inclusion Criteria:
* Willing subjects in good general health.
* Males aged 18 to 60; females aged 50 to 60.
* Subjects who planned to stay in the study area until the end of the study.
Exclusion Criteria:
* Subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result.
* Subjects with a personal or family history of seizures or frank psychiatric disorder.
* Females who had not ceased menstruation; a urine β-human chorionic gonadotrophin (β-HCG) test was to be performed at screening females who had ceased menstruation to exclude pregnancy as a cause.
* Females who were lactating.
* Subjects given antimalarial drugs for treatment within two weeks of study drug initiation.
* Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistry and haematology values.
* Subjects with known hypersensitivity to any of the study drugs.
* Subjects unwilling to remain in the area, report for drug administration or blood drawing during the 3-4 month duration of the study.
* Subjects with G6PD deficiency (as determined by two separate qualitative tests per subject administered using distinct methods; methods used were visual dye and filter paper methods).
* Subjects with any of the following laboratory values: haemoglobin (Hb) \<8g/dL, platelets \<80,000/mm3, white blood cell count (WBC) \<3000/mm3, creatinine \>1.5mg/dL, alanine transaminase (ALT) \>60IU or 1+ haematuria as detected by urine dipstick.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02488902
Study Brief:
Protocol Section:
NCT02488902