Healthy
Conditions
Brief summary
Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers will be administered with the objective to evaluate urine and blood concentrations in healthy volunteers.
Interventions
DRUGTramadol.
Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers.
Sponsors
Parc de Salut Mar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 and ≤ 55 years. * Weight ≥ 50 kg and ≤ 100 kg. * Body mass index (BMI) ≥ 18 and ≤ 30. * Negative serum pregnancy test (women only). * Signed informed consent prior to any study-mandated procedure.
Exclusion criteria
* Smoker of more than 5 cigarettes per day in the last 3 months prior to participate in the study. * History of psychiatric disorders, alcoholism or drug abuse. * Positive urine pregnancy test. * No highly effective anticonception measures during the trial. * Breastfeeding. * Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration. * Any clinically relevant disease or condition (cardiovascular, renal, hepatic, endocrine, hematology, neurology o other acute or chronic diseases) that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety. * Major Surgery last 6 months. * Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption. * Subjects with a clinically significant disease within one month prior to study drug administration. * Any clinically relevant findings in physical examination, vital signs, 12-lead ECG and safety laboratory parameters. * Positive hepatitis or HIV test. * Known hypersensitivity to any drug or drug excipients. * Use of drugs known to induce or inhibit hepatic drug metabolism within one month prior to study administration or during the study and use of citrus juice during the study. * Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within 2 weeks prior to study drug administration. * Intake of more than 5 units per day of beverages containing xanthine (coffee, tea or cola drinks). * Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration. * History of inadequate venous access and/or experience of difficulty donating blood. * Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU. * Subject included in a clinical study within 3 months prior to study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine concentration on Tramadol. | From baseline to 8 hours. |
Secondary
| Measure | Time frame |
|---|---|
| Plasma and dried blood spots (DBS) concentration on Tramadol. | From baseline to 12 hours. |
Other
| Measure | Time frame |
|---|---|
| Adverse effects. | From baseline to 24 hours. |
Countries
Spain
Outcome results
None listed