Healthy male adult
Conditions
Interventions
Single ingestion of test food, Washout(14 days or more), Single ingestion of test food of 2 capsule, Washout(14 days or more), Single ingestion of test food of 4 capsule
Single ingestion of test foo
Sponsors
Alps Pharmaceutical Inc. Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese healthy male volunteers with 20 to 40 years of age when written informed consent is obtained 2) Subjects with BMI of 18.5 and above to below 25.0 at screening test 3) Subjects who are judged as eligible in the screening test by the principal (or sub) doctor 4) Subjects who realize the object and contents of the study and submit the written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects who have a disease under treatment 2) Subjects who are sensitive to drugs or food , or have idiosyncrasy or the history of idiosyncrasy 3) Subjects with allergy disease such as bronchial asthma, pollenosis, atopic dermatitis etc 4) Subjects who have diseases of heart, liver, kidney, digestive organs, respiratory organs and blood function or the history of the diseases or the severe operation history of the diseases and are judged as ineligible to participate in the study by the principal (or sub) doctor (excluding extirpation of appendicitis) 5) Subjects with positive reaction in immunological serum testing at screening test 6) Subjects who take foods for specified health uses , foods with function claims and foods with nutrient function claims (supplements in capsule form and others), excluding those who can stop taking those foods after informed consent) 7) Subjects who cannot keep no smoking in hospital and temperance from 2 days before 8) Subjects who used drugs or took drugs within one week before ingestion of test food or need to use drugs or take drugs in the first period 9) Subjects who participated in other clinical trials and received medication within 12 weeks before ingestion of test food in the first period 10) Subjects who donated 400 mL or 200 mL of blood within 12 or 4 weeks before ingestion of test food or have the schedule of donation of blood component (plasma or platelet) or donated the component within 2 weeks before ingestion of test food in the first period 11) Subjects who are judged as ineligible to participate in the study for other reasons by the principal (or sub) doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt and Cmax calculated from plasma component concentrations at ingestion of test food | — |
Countries
Japan
Contacts
Public ContactShimpei Tomita
New drug research center, Inc. Clinical Research Dept.
Outcome results
None listed