Effect of a pharmaceutical excipient, cremophol EL on the plasma concentration-time profile of saquinavir and fexofenadine after their oral administrations at doses used in the exploratory investigational new drug clinical studies
- Conditions
- healthy male subjects
- Registration Number
- JPRN-UMIN000004621
- Lead Sponsor
- Clinical trial Center,Kitasato University East Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 8
Not provided
1)Any hypersensitivities to saquinavir, fexofenadine or cremophor EL. 2)Any subject with impaired hepatic function. 3)Use of medicine as follow;amiodarone, flecainide, propafenone, bepridil, quinidine, pimozide, ergotamine preparation, simvastatin, midazolam, triazolam, rifampicin, vardenafil, terfenadine, astemizole, cisapride. 4)Use of medicine, health product including Saint John's wort or garlic supplyment 2 weeks before pre-dose. 5)Intake of fruit food and drink including grapefruit juice, orange juice or apple juice from 7 days before pre-dose. 6)Participation to any other clinical reseach in the past 3 months. 7)Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months. 8)Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody. 9)Any allergy to drug and food 10)Drug abuse or positive drug screening 11)Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharamacokinetics of saquinavir and fexofenadine
- Secondary Outcome Measures
Name Time Method safety