healthy male subjects
Conditions
Interventions
oral administration of saquinavir and fexofenadine->
oral administration of saquinavir, fexofenadine and low dose of cremophor EL->
oral administration of saquinavir, fexofenadine and high dose of cremophor EL
Sponsors
Clinical trial Center,Kitasato University East Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Ability to understand and willing to sign the informed consent. 2)Japanese healthy male subjects age 20 to 40 years of age 3)Body weight between 50 kg and 100 kg, and a body mass index(BMI)between 18.5 and 27 kg/m2. 4)Healthy subject as determined by medical history, physical examination, ECGs, and clinical laboratory tests.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharamacokinetics of saquinavir and fexofenadine | — |
Secondary
| Measure | Time frame |
|---|---|
| safety | — |
Countries
Japan
Outcome results
None listed