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OpenTrials
Completed

NCT Number: NCT04688008

Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

The primary objective of the study is to evaluate the relative bioavailability of early phase and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under fasting conditions. The secondary objective of the study is to evaluate the safety of hetrombopag olamine in healthy Chinese adult subjects.

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Key information

Conditions

Bioavailability Study

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

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 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

Drug

Drug: Early phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions

Drug: Late phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions

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 blood 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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, Two -Period, Crossover Study to Investigate the Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations in Healthy Chinese Adult Subjects Under Fasting Conditions.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2020
Registry last updated
Feb 26, 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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