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OpenTrials
Completed

NCT Number: NCT05088343

Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

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

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xueying General Ding

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

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

hetrombopag

Drug

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

Primary outcomes

  1. Peak plasma concentration (Cmax)

    Time frame: 0-72 hours post dose

  2. Area Under the plasma concentration vs time curve (AUC0-72)

    Time frame: 0-72 hours post dose

  3. Area under the blood concentration vs time curve (AUC0-inf)

    Time frame: 0-infinity

Secondary outcomes

  1. Other pharmacokinetics parameters of rosuvastatin

    Time frame: 0-72 hours post dose

    Tmax

  2. The number of volunteers with adverse events as a measure of safety and tolerability

    Time frame: up to Day 20

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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