Healthy Male Subjects
Conditions
Brief summary
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] Antaitavir Hasophate.
Interventions
DRUG[14C] Antaitavir Hasophate
100 mg suspension containing 200µCi of \[14C\] Antaitavir Hasophate
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate | up to 15 days | To investigate the pharmacokinetics of total radioactivity in plasma after oral \[14C\] Antaitavir Hasophate in healthy subjects, and the distribution ratio of total radioactivity in whole blood and plasma |
| Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples) | up to 15 days | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of the Proportion of different metabolites to determine biotransformation pathway of Antaitavir Hasophate | up to 15 days | Proportion of different metabolites(Antaitavir Hasophate and main metabolites） |
| Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data | up to 15 days | The concentrations of Antaitavir Hasophate and main metabolites in plasma |
| Number of adverse events (AE) experienced by subjects | up to 15 days | To examine the safety and tolerability of \[14C\] Antaitavir Hasophate given orally |
Countries
China
Outcome results
None listed