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 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT02817750
Eligibility Criteria:
Inclusion Criteria:
* Male or female volunteers, aged from 18 to 50 years old (women cannot be pregnant or in breastfeeding period and should be committed to use an effective contraceptive method during the study)
* Body mass index (BMI) greater than or equal to 18.5 and less than or equal to 29.9 kg/m2
* Good health conditions or without significant diseases, according to best medical judgment, according to medical history, blood pressure and heart rate measurements, pulse, temperature, physical examination, electrocardiogram (ECG) and complementary laboratory tests
* Ability to understand the nature and objectives of the trial, including risks and adverse events, willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by informed consent form signature.
Exclusion Criteria:
* Know hypersensitivity to the investigational product (Zolpidem) or chemically related compounds
* History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism
* Maintenance therapy with any drugs, except oral contraceptives
* History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic, psychiatric, cardiologic or allergic diseases of any etiology , that requires pharmacological treatment or considered as clinically relevant by the investigator
* Electrocardiographic findings that at investigator discretion are not recommended for study participation
* Deviations on screening laboratory results that are considered as clinically relevant by the investigator
* Smoking
* Intake of more than five cups of coffee or tea per day
* History of abusive use of drugs and alcohol
* Use of regular medication two weeks prior to study enrollment or use of any medications one week prior to study enrollment
* Hospitalization for any reasons up to 8 weeks prior to start of first period of trial treatment
* Treatment within 3 months prior to the start of trial treatment, with any drug with known and well-established toxic potential to major organs
* Participation in any pharmacokinetics trial with more than 300 mL of blood draw or administration of any experimental drug within 12 months prior to trial treatment start
* Donation or loss of 450 mL or more of blood within 3 months prior to trial enrollment or donation of more than 1500 mL of blood within 12 months prior to the trial treatment start
* Positive result for the BHCG urine test, performed by female subjects
* Positive results for the detection of abusive drugs at urine exam
* Result higher than 0.1 mg/L for the etilometer exam
* Any condition, according to investigator's best judgment, that prevents the subject to participate in the trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02817750
Study Brief:
Protocol Section:
NCT02817750