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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT02256735
Eligibility Criteria:
Inclusion Criteria:
* Healthy males or females
* Age 30 to 60 years
* Body mass index (BMI) within 18.5 to 29.9 kg/m2
* In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers are to have given their written informed consent prior to admission to the study
Exclusion Criteria:
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or clinically relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Drug abuse
* Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the reference range if indicative of underlying disease or poor health
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes
* Previous tendon disease related to quinolone treatment
* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
* Heart rate at screening of \> 80 bpm or \< 45 bpm
* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to Pulse rate (PR) interval \> 220 ms, QRS interval \> 115 ms, QTcB \> 450 ms, or QT (uncorrected) \> 470 ms
For Female Subjects:
* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception e.g. sterilization, Intrauterine pessary (IUP), oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT02256735
Study Brief:
Protocol Section:
NCT02256735