Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Chinese Adult Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05088343

Enrollment

Registered

2021-10-21

Start date

2020-09-07

Completion date

2021-01-16

Last updated

2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

Interventions

DRUGRosuvastatin

Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.

DRUGHetrombopag

7.5 mg hetrombopag was administered on Day 6 to Day 11.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

rosuvastatin alone and then in combination with hetrombopag

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026