CompletedPhase 1

A Bioequivalence Study of Hetrombopag in Healthy Subjects

China58 participantsStarted 2021-06-25

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexALL

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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.

What they're measuring

Peak plasma concentration (Cmax)

Timeframe: 0-120 hours post dose

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

Timeframe: 0-120 hours post dose

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

Timeframe: 0-infinity

Trial details

NCT IDNCT05088655

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-25

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