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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02673593
Eligibility Criteria:
Inclusion Criteria:
* Subject is male or female and is aged between 18 and 45 years inclusive.
* Subject's body mass index (BMI) is between 18.0 and 30.0 kg/m2 inclusive.
* Subject is a non-smoker, has been a non-smoker for 3 months prior to screening and has a negative urine cotinine test at screening.
Exclusion Criteria:
* Subject has had a clinically significant illness in the 4 weeks before screening.
* Use of prescribed medication in the 2 weeks before dosing or over-the-counter preparations (including vitamins and supplements) for 1 week before dosing
* Subject has a significant history of drug/solvent abuse, or a positive drugs of abuse (DOA) test at screening or Day -1.
* Subject with a history of alcohol abuse in the opinion of the Investigator, or who currently drinks in excess of 28 units per week (males) or 21 units per week (females), whereby a unit consists of 10ml or 8mg of pure alcohol, or who have a positive alcohol urine test at screening or Day -1.
* Subject has participated in any other clinical study with an investigational drug/device within 3 months before the first day of administration of study treatment.
* Subject has a positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
* Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
* Subject has donated blood or blood products within 3 months before screening.
* Subject has known hypersensitivity to any ingredients of the study treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02673593
Study Brief:
Protocol Section:
NCT02673593