Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
Study Details
Study Description
Brief Summary
Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment rosuvastatin alone and then in combination with hetrombopag |
Drug: Rosuvastatin
Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.
Drug: Hetrombopag
7.5 mg hetrombopag was administered on Day 6 to Day 11.
|
Outcome Measures
Primary Outcome Measures
- Peak plasma concentration (Cmax) [0-72 hours post dose]
- Area Under the plasma concentration vs time curve (AUC0-72) [0-72 hours post dose]
- Area under the blood concentration vs time curve (AUC0-inf) [0-infinity]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xueying General Ding | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
- Principal Investigator: Xueying Ding, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR8735-110