A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CROSSOVER PILOT STUDY WITH TRAMADOL TO VALIDATE TWO EXPERIMENTAL HUMAN PAIN MODELS AT THE KENDLE CLINICAL PHARMACOLOGY UNIT - Pilot study with Tramadol to evaluate 2 painmodels.

Kendle International0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•1. Male, at least 18 years of age, inclusive;
•2. Subjects must voluntarily sign a written informed consent agreement;
•3. Good health, based upon the results of medical history, physical examination, vital signs, ECG, and laboratory tests.

•1. Subject suffering from any (chronic) pain condition and/or diabetes; 2. Any dermatological or neurological condition that may interfere with the assessments done in this study; 3. Presence or history of epilepsy, asthma or bronchitis; 4. Hypersensitivity, intolerance or allergy to relevant drug 5. Hypersensitivity, intolerance or allergy to capsaicin (incl. Capsicum peppers) 6. Subjects who have used prescription medication within 1 week or 5 drug half-lives (whichever is the longer) prior to Day 1; 7. Subjects who have used OTC medication including analgetics within 48 hours prior to Day 1; 8. Positive serology test results for hepatitis B, C or HIV; 9. Presence or history of alcoholism or drug abuse; 10. Positive alcohol breath test result; 11. Positive drug screen result; 12. Participation in an investigational drug study within 3 months prior to Day 1; 13. Unsuitable to participate in the study for any reason in the opinion of the PI.

发起方

Kendle International