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:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT02598856
Eligibility Criteria:
Inclusion Criteria:
In order to participate in this study the subjects must meet all of the following inclusion criteria:
* Provision of a signed written informed consent
* ECG without any pathological abnormalities
* Have a BMI range of 18.5- 26.0 kg/m
* Female subject with child bearing potential must use high efficacy contraception. For the purpose of this study acceptable contraception is defined as sterilization, oral contraceptives, patch, implants, vaginal ring, hormonal IUD or copper IUD through out the study until the last visit.
* Laboratory values within reference values for the following haematology and biochemistry tests:
* Haemoglobin
* Creatinine
* ASAT
* ALAT
* Gamma GT
Exclusion Criteria:
In order to participate in the study subjects must not meet any of the following exclusion criteria:
* using medication on a regular basis, including regular use of nasal spray of any form.
* History of prior drug allergy
* local nasal disease or nasal surgery for the last 2 months
* Pregnant or breast feeding women. A serum HCG below 3 U/L must be demonstrated in females of child-bearing potential at Screening Visit.
* Current drug or alcohol abuse, which in the opinion of the Investigator should preclude participation in the study.
* Having received another new medical chemical entity (defined as a compound which has not been approved for marketing) or having participated in any other clinical study that included drug treatment within 3 months of the administration of investigational product in this study.
* Hypersensitivity to naloxone or any of its excipients.
* Investigator considers subject unlikely to comply with study procedures, restrictions and/or other requirements.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02598856
Study Brief:
Protocol Section:
NCT02598856