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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT05573958
Eligibility Criteria:
Inclusion Criteria:
* Male and female aged ≥ 18 years and above
* Participants able to understand the study procedures and willing to give written informed consent/assent to participate in the trial
* Participants willing to follow the study procedures of the study and available for the entire duration of the study.
* Female participants of childbearing potential must have a negative urine pregnancy test
* Women of childbearing potential (WOCBP) must be willing to abstain from heterosexual activities or agree to use highly effective, double-barrier contraception during the study and for 90 days following the final dose of study treatment, to avoid pregnancy. (This is in line with regulatory Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals)
Exclusion Criteria:
* Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
* Arrhythmias
* Pre-existing hepatic disease
* Pre-existing renal disease
* Already taking any drug
* Pregnancy
* Thyroid dysfunctions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05573958
Study Brief:
Protocol Section:
NCT05573958