none Healthy volunteer
Conditions
Interventions
The following three drugs will be administered to six healthy volunteers in a randomized single-blind cross-over design.
1. Yoku-kan-san (Tsumura) 2.5 g
2. Etizolam 1 mg + lactose 2.4 g
3. Lactose 2.5
D016037, D018592, D011897
single-blind, crossover design, random allocation
Sponsors
Uchida Naoki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: between 20 and 40 years old at the time of obtaining consent. 2) Gender: male 3) BMI (Body Mass Index: kg/m2) is between 18.5 and 25.0 (rounded to the first decimal place). 4) Those who have the capacity to give consent, comply with the rules and regulations during participation in the study, undergo the preliminary examination specified in the study protocol, and report subjective symptoms. 5) Those who are judged to be healthy and eligible to participate in this study by the physician in charge of the research at the preliminary examination specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1) Those with a history of drug abuse/dependence, alcohol abuse/dependence, cardiac, hepatic, renal, pulmonary, occular, or hematologic disease that may affect the evaluation or safety of this study. 2) Those with sleep disturbace with a score of 6 or more evaluated by the Japanese version of Pittsburgh Sleep Quality Index. 3) Those with excessive daytime sleepiness with a score of 11 or more evaluated by the Japanese version of Epworth Sleepiness Scale. 4) Those who had worked or will work a night shift between 2200 and 0700 from a week before the first term until the end of the third term. 5) Those who are taking medications including dietary supplements that may affect the evaluation and safety of this study. 6) Those who have a history of drug allergy. 7) Those who have an allergy to gelatin. 8) Those who have participated in another clinical trial within the last 3 months. 9) Those who are judged by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saccadic eye movement peak velosity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Saccadic eye movement reaction time and inaccuracy 2. Plasma orexin concentration 3. Subjective drowsiness evaluated by Visual Analog Scales | — |
Contacts
Public ContactJun Miura
Showa University Clinical Research Institute for Clinical Pharmacology and Therapeuticsical
Outcome results
None listed