A Bioequivalence Study of Hetrombopag in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Sever Aplastic Anaemia
• Intervention / Treatment: Drug: Hetrombopag Olamine Tablet

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • The People's Hospital of Liaoning Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: T - R- R	Drug: Hetrombopag Olamine Tablet; Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
Experimental: Treatment group B: R -T - R	Drug: Hetrombopag Olamine Tablet; Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
Experimental: Treatment group C: R- R-T	Drug: Hetrombopag Olamine Tablet; Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Anemia; Bone Marrow Failure Disorders; Anemia, Aplastic
• Other Study ID Numbers: SHR8735-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No