A Bioequivalence Study of Hetrombopag in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05088655

Enrollment

Registered

2021-10-22

Start date

2021-06-25

Completion date

2023-11-02

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sever Aplastic Anaemia

Brief 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.

Interventions

DRUGHetrombopag Olamine Tablet

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Peak plasma concentration (Cmax)	0-120 hours post dose
Area Under the plasma concentration vs time curve (AUC0-120)	0-120 hours post dose
area under the plasma concentration vs time curve (AUC0-inf)	0-infinity

Secondary

Measure	Time frame
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)	0-120 hours post dose
Half-life Associated With the Terminal Slope (t½)	0-120 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 26

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026