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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT03283267
Eligibility Criteria:
Key Inclusion Criteria:
1. Provision of informed consent prior to any study specific procedures
2. Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who reside in Hong Kong
3. Ability to have repeated blood draws or effective venous catheterization
4. Willing to consume food and beverages using a standardized daily diet containing 40 (± 10%) mEq/day sodium and 128 (± 10%) mEq/day potassium provided by the research site
Key Exclusion Criteria:
1. Participation in another clinical study with an investigational product during the last 3 months
2. Subjects who were receiving concomitant medications including vitamins, dietary supplements and herbal preparations within 2 weeks prior to Study Day 1 of the Diet Run-in Period.
3. Current and/or past history of alcohol abuse within the past year or a positive results (exceed normal range) of breath test for alcohol abuse
4. Current and/or past history of drugs abuse within the past year or a positive drug abuse screen, e. g. methylenedioxymethamphetamine, opiate, barbiturates, benzodiazepines, ketamine, cocaine, amphetamine, methamphetamine, marijuana, and methadone.
5. Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03283267
Study Brief:
Protocol Section:
NCT03283267