Clinical trial
Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects
Name
SHR8735-114
Description
This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.
Trial arms
Trial start
2021-06-25
Estimated PCD
2022-07-25
Trial end
2023-11-02
Status
Completed
Phase
Early phase I
Treatment
Hetrombopag Olamine Tablet
Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
Arms:
Treatment group A: T - R- R, Treatment group B: R -T - R, Treatment group C: R- R-T
Size
58
Primary endpoint
Peak plasma concentration (Cmax)
0-120 hours post dose
Area Under the plasma concentration vs time curve (AUC0-120)
0-120 hours post dose
area under the plasma concentration vs time curve (AUC0-inf)
0-infinity
Eligibility criteria
Inclusion Criteria:
1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
Exclusion Criteria:
1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. History of deep vein thrombosis, or any other thromboembolic event;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}
Updated at
2023-12-04
1 organization
1 product
1 indication
Organization
Jiangsu HengRui MedicineProduct
Hetrombopag OlamineIndication
Severe Aplastic Anemia