Oral Tramadol Hydrochloride Study in Healthy Volunteers to Improve Detection in Anti‑Doping Tests
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study involves people who are healthy and do not have any known medical condition. Participants will receive a single dose of tramadol hydrochloride taken by mouth. The medication is given to see how it appears and disappears in the body, which helps improve testing methods used in anti‑doping programs.
The purpose of the study is to describe the pharmacokinetic behavior of the drug by measuring its concentration over time in plasma, the liquid part of blood, and to record any adverse events, which are unwanted side effects. After taking the medication, volunteers will stay in the clinic for a short period during which blood samples will be collected at several time points. Throughout the visit, researchers will watch for any signs of discomfort or other reactions, and participants will be asked about how they feel.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Age: You must be at least 18 years old and no older than 55 years.
- Weight: Your body weight must be between 50 kilograms (about 110 pounds) and 100 kilograms (about 220 pounds).
- Body mass index (BMI): Your BMI, a number that compares your weight to your height, must be between 18 and 30.
- Negative serum pregnancy test (women only): A blood test must show that you are not pregnant.
- Signed informed consent: You must sign a consent form that explains the study before any study procedures are done.
Who cannot join the trial?
20 criteria
- You must not be a smoker who has smoked more than 5 cigarettes per day in the three months before the study.
- You cannot have had a clinically significant disease (a serious illness) within one month before taking the study drug.
- If any important problems are found during a physical exam, checking your vital signs (like blood pressure and heart rate), a 12‑lead ECG (a test that records the heart’s electrical activity), or lab tests, you will be excluded.
- A positive test for hepatitis (liver infection) or HIV (human immunodeficiency virus) will keep you from joining.
- If you are known to have hypersensitivity (allergy) to any medication or its inactive ingredients, you cannot participate.
- You must not have used medicines that change how the liver processes drugs (hepatic drug metabolism) within one month before the study or during the study, and you cannot drink citrus juice while in the study.
- You cannot take any prescription or over‑the‑counter (OTC) products, including herbal remedies, homeopathic medicines, vitamins, minerals, or nutritional supplements, within two weeks before the study drug is given.
- You must not consume more than five servings per day of foods or drinks that contain xanthine (such as coffee, tea, or cola).
- You must not have donated blood or plasma, received a blood or plasma transfusion for medical reasons, or plan to donate blood or plasma within one month before or after receiving the study drug.
- If you have a history of poor venous access (difficulty finding a vein) or have had trouble donating blood, you cannot join.
- You must be willing and able to follow diet, exercise, and alcohol or xanthine‑containing beverage restrictions while not in the study center.
- A history of psychiatric disorders (mental health conditions), alcoholism, or drug abuse will exclude you.
- If you have taken part in another clinical study within the past three months, you cannot participate.
- A positive urine pregnancy test will keep you from joining.
- You must use a highly effective form of birth control (anticonception) during the trial; not doing so will exclude you.
- If you are currently breastfeeding, you cannot take part.
- A positive test for illegal drugs or a positive alcohol breath test before taking the study drug will exclude you.
- Any serious disease or condition affecting the heart, kidneys, liver, hormones, blood, nerves, or other major systems that the investigator believes could interfere with study procedures, affect the results, or put your safety at risk will exclude you.
- You cannot have had major surgery within the last six months.
- Ongoing digestive system problems or a history of gastrointestinal surgery that could affect how your body absorbs the study drug will keep you from participating.
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Investigated drugs
Tramadol is a pain‑relieving medication that is taken by mouth. In this study, healthy volunteers receive tramadol so researchers can learn how the drug shows up in blood and other body fluids. The information helps improve tests that look for tramadol use in sports anti‑doping programs, by showing how long the drug stays in the body and how it is broken down.
What is already known about the treatment
Investigated diseases
Conditions this trial is registered against
sourced from the EU Clinical Trials Register and site verification
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