healthy volunteer
Conditions
Interventions
coadministration of salazosulfapyridine and rosuvastatin without curcumin
coadministration of salazosulfapyridine and rosuvastatin with curcumin
Sponsors
APDD
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: the investigors must ensure that all subjects being considerd meet the following inclusion criteria 1) capable to understand and sign the informed consent. 2) 20-45 years of age 3)BMI 17.6-26.4 4)genotype result shows one of the following groups; A)BCRP wild homo/OATP2B1 wild homo B)BCRP wild homo/OATP2B1mut/wild 5)good health as determined by physical examination, vital signs ECG and laboartory tests.
Exclusion criteria
Exclusion criteria: the investigors must ensure that all subjects being considerd meet the following exclusion criteria or conditions 1) blood disorder and impairment of liver and kidney function 2) history of asthma 3) porphyria patient 4) deficiency of glucose-6-phosphdehydrogenase 5) impairment of liver or kidney functions 6) grapefruit, orange and apple juice intake within 7 days prior to test drug administration 7) regular use of St. John's Wort 8) recent (past 4 months) participation in other clinical trial using new chemical entity 9) donation of 400mL or more of blood within 3 months prior to participation, donation of 200mL or more of blood within 1 month prior to participation, or donation of component blood within 2 weeks prior to participation 10) positive serologic reaction of syphilis, positive result of HIV test, HBsAg and HCVAb 11) history of multiple and recurring allergies to medicines or food 12) history of drug or alcohol abuse and capable to refrain from alcohol for the designated term 13) the investigator determines this trial participation inadequate by the information at the screening visit 14) vulnerable to alcohol or incapable to intake alcohol 15) the investigator determines this trial participation inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters of salazosulfapyridine and rosuvastatin plasma concentration | — |
Countries
Japan
Outcome results
None listed