Study of the effect of modification of slow wave sleep by hypnotics on glucose tolerance in healthy male volunteers

Not Applicable

• Conditions: healthy male volunteers

• Registration Number: JPRN-UMIN000006624
• Lead Sponsor: Kitasato University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified