Pharmacokinetic investigation into the formation of carbamazepine metabolites and carbamazepine-protein conjugates in healthy volunteers: a non-randomised study

Royal Liverpool and Broadgreen University NHS Trust (UK)0 个研究点目标入组 8 人开始时间: 2014年10月22日最近更新: 2021年10月4日

试验速览

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33217013/ (added 21/09/2021)

•1. Subject is not willing to take part or unable to give written informed consent
•2. Subject has clinically significant abnormal medical history or physical exam
•3. Subject has history of febrile illness within 4 weeks prior to admission
•4. Subject has clinically significant abnormal laboratory test at screening including HBV/HCV/HIV
•5. Subject has taken any interacting prescription or non-prescription drug, or dietary supplements within 2 weeks prior to study admission. Herbal supplements must be discontinued at least 4 weeks prior to admission to the clinical research facility
•6. Subject possesses either the HLA-B*1502 or HLA-A* 3101 genotype
•7. Subject has a clinically significant ECG abnormality ? prolonged corrected QT >450 ms, 2nd or 3rd degree atrioventricular conduction block
•8. Subject has known hypersensitivity to carbamazepine or structurally related drugs (e.g. tricyclic antidepressants) or any other component of the formulation
•9. Subject with history of bone marrow depression
•10. Subject with history of hepatic porphyrias (e.g. intermittent porphyria, variegate porphyria, porphyria cutanea tarda)
•11. Subject has taken part on another research study within 90 days of commencement
•12. Subject has any condition which in the opinion of the investigator will interfere with the study

发起方

Royal Liverpool and Broadgreen University NHS Trust (UK)