Healthy male adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male subjects ranging in age from 20 to 34 at informed consent. 2) Subjects who can give informed consent to partake in this study after being provided with an explanation of the experimental protocol detail. 3) Subjects ranging in BMI from not less than 18.5 but less than 25.0 kg/m2.
Exclusion criteria
Exclusion criteria: (1) Subjects taking steadily (not less than three times a week) in the following affecting foods; health-specific, functional, and health foods (mainly amino acids), with any difficulty in refraining from having those after the consent. (2) Subjects taking medicine steadily, owing to some kind of disease. (3) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. 4) Subjects with drug/alcohol/food allergy. 5) Subjects being under another clinical research with some kind of medicine or health food, or who partook in that within four weeks before this study, or planning to take part in other clinical researches after giving informed consent to participate in this study. (6) Subjects who donated a 200 mL of their whole blood and/or blood components within a month before this study. (7) Subjects who donated a 400 mL of their whole blood within the last three months to this study. (8) Subjects who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the blood amounts planning to be sampled in this study. 9) At a point of the screening test, subjects having some kind of infection. 10) Others who have been determined as ineligible for participation in this study, judging from the principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC and deltaAUC of total amino acids | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. AUC, Tmax, Cmax, deltaAUC, and deltaCmax of blood-glucose level 2. AUC, Tmax, Cmax, deltaAUC, and deltaCmax of insulin level in blood 3. AUC, Tmax, Cmax, deltaAUC, and deltaCmax of each amino acid in blood | — |
Countries
Japan
Contacts
CPCC Company Limited Clinical Planning Department