Healthy Male Subjects Clinical Trial
Official title:
Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Yiqibuvir in Healthy Male Participants
Verified date | July 2023 |
Source | Sunshine Lake Pharma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] Yiqibuvir.
Status | Completed |
Enrollment | 8 |
Est. completion date | September 12, 2023 |
Est. primary completion date | September 12, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai xuhui central hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Sunshine Lake Pharma Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples) | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces. | up to 18 days | |
Secondary | Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir | Proportion of different metabolites(Yiqibuvir and main metabolites) | up to 18 days | |
Secondary | Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data | The concentrations of Yiqibuvir and main metabolites in plasma | up to 18 days | |
Secondary | Number of adverse events (AE) experienced by subjects | To examine the safety and tolerability of [14C] Yiqibuvir given orally | up to 18 days |
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