Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

Hengrui Medicine

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Hetrombopag

Drug: Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05088343

SHR8735-110

Details and patient eligibility

About

Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.