healthy male volunteers
Conditions
Interventions
oral administartion of triazolam
oral administartion of zolpidem tartrate
Sponsors
Kitasato University
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)A body mass index(BMI)between 18 and 30 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 triazolam and or zolpidem tartrate. 2)Any subject with hepatic or renal disease requiring treatment. 3)QT prolongation over 460 ms on ECG. 4)Use of medicine, health product including Saint John's wort 7 days 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)Drug abuse or positive drug screening. 10)Anyone known to have a sleep disorder including insomnia, sleep apnea syndrome or restless legs syndrome in the past 3 months. 11)Use of medicine influences sleep including hypnotic drug,psychotropic drug or nonprescription sleep aid in the past 3 months. 12)any subjects with abnormal glucose level or HbA1c. 13)Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSG glucose tolerance | — |
Secondary
| Measure | Time frame |
|---|---|
| AHI,3%ODI, PLMI PVT, DSST R-R interval, LF, HF, LF/HF, active mass LARS, KSS, SMH | — |
Countries
Japan
Outcome results
None listed