Overview

Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

Status:
Completed
Trial end date:
2021-01-16
Target enrollment:
0
Participant gender:
All
Summary
Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Treatments:
Rosuvastatin Calcium
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.