Status:
COMPLETED
ADME Study of [14C] Yiqibuvir in Healthy Male Subjects
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Healthy Male Subjects
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] Yiqibuvir.
Eligibility Criteria
Inclusion
- signing of informed consent
- Weight: Body mass index (BMI) is 19.0\~28.0 kg/m2
- Subjects are able to communicate well with the investigators and be able to complete the trial according to the process
Exclusion
- Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
- Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
- Positive results from urine drug screen test
- Donate blood or lose blood 400 mL or more within 3 month prior to dosing
- Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication
- History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05998304
Start Date
August 7 2023
End Date
September 12 2023
Last Update
February 21 2024
Active Locations (1)
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1
Shanghai xuhui central hospital
Shanghai, Shanghai Municipality, China