A Bioequivalence Study of Hetrombopag in Healthy Subjects

Phase 1

Completed

• Conditions: Sever Aplastic Anaemia
• Interventions: Drug: Hetrombopag Olamine Tablet

• Registration Number: NCT05088655
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-25
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-22
• Primary Completion: 2022-07-25
• Study Completion: 2023-11-02
• Last Update Submitted: 2023-11-30
• Status Verified: 2023-12
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment group C: R- R-T	Hetrombopag Olamine Tablet	-
Treatment group A: T - R- R	Hetrombopag Olamine Tablet	-
Treatment group B: R -T - R	Hetrombopag Olamine Tablet	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The People's Hospital Of Liaoning Province; 🇨🇳 Shenyang, Liaoning, China