healthy male
Conditions
Interventions
ritonavir, saquinavir, pravastatin, midazolam, fexofenadine
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) 20-45 years of age 3)BMI 18.5-25.0 4)good health as determined by physical examination, vital signs and laboartory tests.
Exclusion criteria
Exclusion criteria: the investigors must ensure that all subjects being considerd meet the following exclusion criteria or conditions: 1)history of allergy to any drugs 2)medical attention within 2 months prior to participation 3)donation of 200mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4)donation of 400mL or more of blood within 12 weeks prior to participation 5)recent (past 4 months) participation in other clinical trial for investigational new chemical entity 6)history of drug abuse 7)alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK profile of ritonavir, saquinavir, pravastatin, midazolam, fexofenadine | — |
Countries
Japan
Contacts
Public ContactMiyuki Kimura
ETA Kyushu Clinical Pharmacology Clinic
Outcome results
None listed