none Healthy volunteer
Conditions
Interventions
Oral administration of Lina Green 21 Premium, a supplement containing midazolam and spirulina, to healthy adult males.
Sponsors
Takehiko Sambe
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Age: 18 years old or older and under 45 years old at the time of obtaining consent. 2) Gender: male 3) BMI: 18.5 kg/m2 or more but less than 30.0 kg/m2 4) Persons who have the ability to consent, abide by the rules of compliance during participation in the study, undergo the pre-test specified in this study protocol, and are able to report subjective symptoms, etc. (5) Persons who have been judged by the physician in charge of the research to be eligible to participate in this study based on the preliminary examination specified in the protocol for this study.
Exclusion criteria
Exclusion criteria: Persons who have any of the following will not be included in this study. (1) Persons with a history of drug abuse or dependence, alcohol abuse or dependence, or heart, liver, renal, pulmonary, ocular, or hematologic disease that may affect the safety or the evaluation of this study. (2) Patients who are taking drugs (including dietary supplements and dietary supplements) that may affect the evaluation and safety of this study. (3) Have a history of drug allergy (4) Persons who regularly use excessive amounts of alcohol (those who are unable to maintain abstinence from alcohol during the study period) (5) Those who have participated in other clinical trials within 3 months of the study. (6) Other subjects who are judged by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of serum midazolam (AUC, Cmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of serum midazolam (t1/2, tmax) | — |
Contacts
Public ContactRyu Kakei
SHOWA Medical University
Outcome results
None listed