health male subjects
Conditions
Interventions
sulfasalazine and 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) Japanese healthy male who is capable to understand and sign the informed consent. 2) 20-35 years of age 3)BMI 18.0-25.0 4)good health as determined by physical examination, vital signs and laboartory tests etc..
Exclusion criteria
Exclusion criteria: the investigors must ensure that all subjects being considerd meet the following exclusion criteria or conditions: 1)any impairment of blood, liver and kidney 2)asthma 3)Acute Intermittent Porphyria 4)Glucose-6-phosphate dehydrogenase deficiency 5)any medication and food ingestion containing curcumin within 7 days prior to test drug administration 6)fruit juice ingestion containing grapefruit, orange or apple within 7 days prior to test drug administration 7)dialy user of St. John's wort 8)recent (past 4 months) participation in other clinical trial for investigational new chemical entity 9)donation of 400mL or more of blood within 12 weeks prior to participation, donation of 200mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 10)positive results on HBs-AG, HCV-AB, HIV-AB, TPHA 11)history of allergy to any drugs and foods 12)history of drug or alcohol abuse and incapable of abstinence from smoking and alcohol during protocol designated period 13)excess daily alcohol ingestion 14)inappropriate subject as determined by physical examination, vital signs, laboartory tests and ECG at screening 15)history of sulfasalazine administration (either clinical research or medication) 16)vulnerable for alcohol intake 17)inappropriate subjects as determined by phsicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| salfasalazine PK profiles | — |
Countries
Japan
Contacts
Public ContactSaiko Yamada
OPHAC Hospital pharmacy
Outcome results
None listed