Status:
COMPLETED
OPC-61815 in Healthy Chinese Male Subjects
Lead Sponsor:
Otsuka Beijing Research Institute
Conditions:
Healthy Adult Male
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of OPC-61815 in healthy Chinese Male subjects
Detailed Description
To evaluate the pharmacokinetic (PK) characteristics of single and multiple intravenous administration of OPC-61815 in healthy Chinese subjects. To evaluate the safety of single and multiple intraven...
Eligibility Criteria
Inclusion
- Healthy male subjects aged 18-45 years (including the cutoff values, subject to the time of signing the Informed Consent Form (ICF));
- Body mass index (BMI) of 19-26 kg/m2 (including the cutoff values), with a body weight of not less than 50 kg for male subjects;
Exclusion
- Those whose the sitting pulse is lower than 50 beats/min or higher than 100 beats/min after resting for over 3 minutes.
- Those whose sitting SBP is lower than 90 mmHg or higher than 140 mmHg, or DBP is lower than 50 mmHg or higher than 90 mmHg after resting for over 3 minutes.
- Various micturition disorders (pollakiuria or dysuria, etc.).
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05439148
Start Date
June 30 2022
End Date
September 21 2022
Last Update
October 13 2023
Active Locations (1)
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1
Clinical Pharmacology Research Center, Peking Union Medical College Hospital
Beijing, China