Effect of terbinafine and itraconazole on the pharmacokinetics and pharmacodynamics of oral tramadol: A three-phase randomized balanced cross-over study in healthy volunteers

niversity of Turku0 个研究点开始时间: 2009年12月1日最近更新: 2014年10月27日

试验速览

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•-Twelve male or female adult non-smoking volunteers
•-aged 18-40 years
•-body weights within ±15% of the ideal weight for height
•-no previous or chronic diseases
•laboratory testing to prove that they are in good health.
•-negative result in modified Finnish version of the Abuse Questions
•-normal laboratory screening results
•-negative urine sample for glucose, proteins and drugs with addiction potential
•-Blood pressure in sitting position must be within normal limits
•-Base line ECG must be normal
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.A previous history of intolerance to the study drugs or to related compounds and additives.
•2.Concomitant drug therapy of any kind for at least 14 days prior to the study.
•3.Subjects younger than 18 years and older than 40 years.
•4.Existing or recent significant disease.
•5.History of hematological, endocrine, metabolic or gastrointestinal disease, including gut motility disorders.
•6.History of asthma or any kind of drug allergy.
•7.Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
•8.A positive test result for urine toxicology.
•9.A yes” answer to any one of the Abuse Questions.
•10.Pregnancy or nursing.
•11.Donation of blood for 4 weeks prior and during the study.
•12.Special diet or life style conditions which would compromise the conditions of the study or interpretation of the results.
•13.Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
•14.Smoking for one month before the start of the study and during the whole study period.
•15.Any history of coagulation abnormality, also in first degree relatives

发起方

niversity of Turku