ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects

Sunshine Lake Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: [14C] Antaitavir Hasophate

Study type

Interventional

Funder types

Industry

Identifiers

NCT05446233

HEC74647-P-04/CRC-C2222

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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