A Bioequivalence Study of Hetrombopag in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Sever Aplastic Anaemia

Treatments: Drug: Hetrombopag Olamine Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05088655

SHR8735-114

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);

Exclusion criteria

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. History of deep vein thrombosis, or any other thromboembolic event;
5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 3 patient groups

Treatment group A: T - R- R

Experimental group

Treatment:

Drug: Hetrombopag Olamine Tablet

Treatment group B: R -T - R

Experimental group

Treatment:

Drug: Hetrombopag Olamine Tablet

Treatment group C: R- R-T

Experimental group

Treatment:

Drug: Hetrombopag Olamine Tablet