Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
- Registration Number
- NCT05088343
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.
- Detailed Description
The primary objective of the study is to evaluate the effect of hetrombopag on pharmacokinetics of healthy Chinese adult subjects after oral administration of rosuvastatin calcium tablets. The secondary objective of the study is to evaluate the safety of rosuvastatin alone and when co-administered with hetrombopag.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 55 (including 18 and 55) at the date of signing the informed consent;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26).
Exclusion Criteria
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
- History of deep vein thrombosis, or any other thromboembolic event;
- 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.
- Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment Rosuvastatin rosuvastatin alone and then in combination with hetrombopag Treatment Hetrombopag rosuvastatin alone and then in combination with hetrombopag
- Primary Outcome Measures
Name Time Method Area Under the plasma concentration vs time curve (AUC0-72) 0-72 hours post dose Peak plasma concentration (Cmax) 0-72 hours post dose Area under the blood concentration vs time curve (AUC0-inf) 0-infinity
- Secondary Outcome Measures
Name Time Method Other pharmacokinetics parameters of rosuvastatin 0-72 hours post dose Tmax
The number of volunteers with adverse events as a measure of safety and tolerability up to Day 20
Trial Locations
- Locations (1)
Xueying General Ding
🇨🇳Shanghai, Shanghai, China