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OpenTrials
Completed

NCT Number: NCT05088655

A Bioequivalence Study of Hetrombopag in Healthy Subjects

This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.

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Key information

Conditions

Sever Aplastic Anaemia

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The People's Hospital Of Liaoning Province

Shenyang, Liaoning, 110016, China

Who can participate

Healthy volunteers accepted: No

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 45 (including 18 and 45) at the date of signing the informed consent;
  • 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.

Treatment and study plan

Hetrombopag Olamine Tablet

Drug

Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)

Primary outcomes

  1. Peak plasma concentration (Cmax)

    Time frame: 0-120 hours post dose

  2. Area Under the plasma concentration vs time curve (AUC0-120)

    Time frame: 0-120 hours post dose

  3. area under the plasma concentration vs time curve (AUC0-inf)

    Time frame: 0-infinity

Secondary outcomes

  1. Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)

    Time frame: 0-120 hours post dose

  2. Half-life Associated With the Terminal Slope (t½)

    Time frame: 0-120 hours post dose

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

    Time frame: up to Day 26

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 22, 2021
Registry last updated
Dec 4, 2023

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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