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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT02329561
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult male or female volunteers, 18-40 years of age.
* Adult male or female volunteers aged 75 years or more
* Subjects with a BMI less than 35 kg/m2.
* Generally healthy, elderly subjects with mild renal impairment (creatinine clearance 50-80 mL/min or glomerular filtration rate ≥ 50 mL/min/1.73 m2) or mild hepatic impairment (Child-Pugh Class A)
* Medically stable healthy subjects with non-clinically significant laboratory profiles, vital signs and ECGs.
* Subjects will be non-smokers for at least 3 months prior to the first dose or consistent moderate smokers (fewer than 10 cigarettes per day) for at least 3 months prior to the first dose.
* Females of childbearing potential must be using medically acceptable birth control methods
* Voluntary written informed consent
Exclusion Criteria:
* History or presence of significant unstable or untreated cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* alcoholism or drug abuse within the past year;
* previous or current opioid dependency or other substance abuse or dependence, other than nicotine;
* hypersensitivity or idiosyncratic reaction to tramadol hydrochloride, codeine, opioids or other synthetic opioids of the aminocyclohexanol group;
* seizures (other than infantile febrile seizures);
* significant head trauma.
* Subjects who tested positive at screening for HIV, HBsAg or HCV.
* Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or prior to dosing.
* Subjects whose pulse is lower than 55 b.p.m. at screening or prior to dosing for young subjects or less than 60 b.p.m at screening or prior to dosing for the elderly subjects.
* Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
* Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
* Subjects who are revealed upon genotyping to be CYP2D6 poor metabolisers.
* Subjects who have received monoamine oxidase inhibitors (MAOI) or antidepressants (tricyclic or SSRIs), within 28 days prior to the first dose.
* Subjects who have received drugs belonging to the opioids/analgesic class, within 5 elimination half-lives prior to the first dose.
* Subjects who have received coumarin derivatives (e.g warfarin) or digoxin, within 28 days prior to the first dose.
* Subjects who have received CNS depressant drugs (such as benzodiazepines, barbiturates, sedative H1 antihistamines, neuroleptics, some beta-blockers, anxiolytics other than benzodiazepines), tricyclic compounds (such as cyclobenzaprine, promethazine), drugs increasing serotonin levels or thalidomide within 5 elimination half-lives prior to the first dose.
* Subjects with significant liver disease (Child-Pugh Score greater than or equal to 7).
* Significant renal disease as determined by the Cockcroft-Gault formula
* Bowel disease affecting absorption.
* Major illness requiring hospitalization during the last 3 months prior to the first dose.
* Previous failure of treatment with tramadol or discontinuation of treatment with tramadol due to adverse events.
* Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Subjects who have any condition that, in the opinion of the Investigator, makes the subject unsuitable for the study.
* Subjects who donated significant amounts of blood in the last year
* Subjects who have participated in another clinical trial within 28 days prior to the first dose.
* Subjects who are unable to tolerate the training for the ESEPM.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02329561
Study Brief:
Protocol Section:
NCT02329561