Healthy participants
Conditions
Interventions
OPF1 group (OPF-105, 550 mL, 2 hours)
BFI1 group (BFI, 500 mL, 2 hours)
OPF2 group (OPF-105, 1100 mL, 4 hours)
BFI2 group (BFI, 1000 mL, 4 hours)
OPF3 group (OPF-105, 2200 mL, 8 hours)
BFI3 group (BFI
Sponsors
Otsuka Pharmaceutical Factory, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Those who aged 20 or over to under 40 at the time of obtaining consent (2) Those who are observed no abnormalities in both arms and are able to establish peripheral venous access (3) Those whose body mass index is 18.5 or more and less than 30.0 (4) Those who provided written informed consent
Exclusion criteria
Exclusion criteria: (1) Those who have gastrointestinal, hepatic, renal, cardiovascular, blood, endocrine, and lipid metabolism abnormalities (including a history of these) and are determined to be difficult to participate in the clinical trial by the principal investigator or sub-investigator (2) Those who are determined not to be suitable as a participant of the clinical trial by the principal investigator or sub-investigator based on the subjective symptoms/objective findings, vital signs, or observation/measurement results of clinical tests (3) Those who tested positive for infectious diseases (hepatitis B, hepatitis C, HIV, or syphilis) (4) Those who have a history of hypersensitivity to the ingredients of the test or control solutions (5) Those who underwent blood sampling or participated in blood donation of more than 200 mL within 4 weeks before the informed consent was obtained Those who underwent blood sampling or participated in blood donation of more than 400 mL, within 12 weeks before the day of obtaining informed consent (6) Those who participated in a clinical trial or clinical study and received a drug within 16 weeks before the day of obtaining informed consent (7) Those who have a history or presence of alcohol or drug abuse (8) Those who used drugs (including over-the-counter drugs) and consumed foods with health claims (those judged by the principal investigator or sub-investigator to affect this trial) within 2 weeks before the participant registration date (9) Those who are determined not to be suitable as a participant of the clinical trial by the principal investigator or sub-investigator for any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Clinical laboratory tests, Vital signs, Subjective symptoms/objective findings, Physical examination, and Electrocardiography) | — |
Secondary
| Measure | Time frame |
|---|---|
| Ingredient-related parameters (Clinical laboratory tests) | — |
Countries
Japan
Contacts
Public ContactSatoshi Katayose
Otsuka Pharmaceutical Factory, Inc. Clinical Development Department, Research and Development Center
Outcome results
None listed