A Clinical Study Comparing the Bioavailability of HRS-2189 Tablets
ConditionMalignant Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
This study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets in healthy subjects.
Eligibility criteria
Qualifiers
Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be able to complete the research in accordance with the trial protocol requirements.
Participants signed the informed consent form. Their age on the day of the event was between 18 and 45 years old (inclusive of both ends).
Female weight ≥ 45 kg, male weight ≥ 50 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 [BMI = weight (kg) / height2 (m2)] (including both endpoints).
Female participants with reproductive capacity must agree to practice contraception and avoid egg donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Blood serum pregnancy tests must be negative before and during the trial, and they must not be in the lactation period. Male participants whose partners have reproductive capacity must agree to practice contraception and avoid sperm donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug.
Disqualifiers
Those who have had or currently have any clinical history of serious diseases in the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolism, or any chronic diseases or other diseases that may interfere with the test results.
Those who have undergone major surgical procedures within one year prior to signing the informed consent form, or who have undergone any surgery within one month prior to signing the informed consent form, or who plan to undergo surgery during the trial period.
Has a history of drug allergy, or is known to be allergic to the study drug/related drugs or excipients.
Those who have a history of drug use or substance abuse, or who have a positive result in drug screening tests.
Trial design
Treatments tested in this trial
- HRS-2189 Tablet
Treatment groups
28 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov