JPRN-UMIN000036938Completed未知
Pharmacokinetic comparative study of plant-derived components in healthy male volunteers - Pharmacokinetic comparative study of plant-derived components in healthy male volunteers
Alps Pharmaceutical Inc. Co., Ltd.0 sites10 target enrollmentStarted: June 3, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 40years-old (—)
- Sex
- Male
Inclusion Criteria
- Not provided
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
Investigators
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