JPRN-jRCT2051220144
Recruiting
Phase 1
Phase I/II trial for safety and pharmacokinetics of ENDOPIN in healthy adults and patients with postoperative pain
akajima Takako0 sites46 target enrollmentJanuary 4, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Phase 1 part: Healthy adult male Phase 2 part: Postoperative pain patients
- Sponsor
- akajima Takako
- Enrollment
- 46
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Phase 1 Part
- •1\) Male age between 18 and 40 years old at the time consent is obtained.
- •2\) All of the following are met at the pre\-enrollment examination
- •Hemoglobin level more than or equal to 10 g/dL
- •White blood cell count more than or equal to 3,000 /micro\-L
- •Platelet count more than or equal to 100,000/micro\-L
- •AST (GOT) less than or equal to 50 U/L
- •ALT (GPT) less than or equal to 50 U/L
- •Total bilirubin less than or equal to1\.5 mg/dL
- •Serum creatinine less than or equal to 1\.5 mg/dL
Exclusion Criteria
- •Phase 1 Part
- •1\) Patient has one of the following complications
- •Serious hepatic or renal disease
- •Cardiac dysfunction equivalent to NYHA II degree or higher
- •History of malignancy or liver disease requiring treatment
- •2\) Positive infectious disease test at screening: HBs antigen/antibody, HBc antibody, HCV antibody, HIV antigen/antibody, syphilis, tuberculosis
- •3\) Positive PCR test for novel coronavirus at the time of admission
- •4\) Those diagnosed with infectious gastroenteritis within 7 days prior to enrollment (including family members living in the same household)
- •5\) Has food allergy or drug hypersensitivity or has a history of such allergy or drug hypersensitivity.
- •6\) Has alcohol or drug dependence or a history of alcohol or drug dependence.
Outcomes
Primary Outcomes
Not specified
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