Exploratory trials evaluating the pharmacokinetics of Quinidine and Verapamil after oral administration in healthy male subjects
- Conditions
- Healthy male subjects
- Registration Number
- JPRN-UMIN000004094
- Lead Sponsor
- APDD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 8
Not provided
The following subjects shall be excluded from this study: (1)The subject has any medical history that is not considered as eligible for inclusion in this study by the investigator. (2)The subject has the disease which needs a treatment at present. (3)The subject is currently participating in another clinical study and is exposed to an investigational drug. (4) The subject has any medical history of known allergy or hypersensitivity to quinidine, verapamil, fexofenadine, midazolam, celiprorol and itraconazole. (5) The subject has donated whole blood">400mL" within the previous 3 months or ">200mL" within the previous 1 month, and components of blood(apheresis) within the previous 2 weeks. (6) The subject has hypersensitivity to any drugs and foods. (7) The subject has a history or current conditions of drug abuse or alcoholism. (8)The subject is positive for HBs antigen, syphilis, HCV antibody, HIV antigen/antibody. (9)The subject has any clinically relevant abnormality on vital sign, clinical laboratory test, ECG and medical examination. (The subject who admitted participation in this study in the judgement of investigator excludes.) (10)Any subjects considered to be unsuitable for the study by the reseacher.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of Quinidine and Verapamil
- Secondary Outcome Measures
Name Time Method