A phase I clinical pharmacology study of OPF-105 in healthy adult male
- Conditions
- Healthy participants
- Registration Number
- JPRN-UMIN000046915
- Lead Sponsor
- Otsuka Pharmaceutical Factory, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 48
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (Clinical laboratory tests, Vital signs, Subjective symptoms/objective findings, Physical examination, and Electrocardiography)
- Secondary Outcome Measures
Name Time Method Ingredient-related parameters (Clinical laboratory tests)