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A Bioequivalence Study of Hetrombopag in Healthy Subjects

Primary Purpose

Sever Aplastic Anaemia

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Hetrombopag Olamine Tablet
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sever Aplastic Anaemia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • The People's Hospital Of Liaoning Province

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Treatment group A: T - R- R

Treatment group B: R -T - R

Treatment group C: R- R-T

Arm Description

Outcomes

Primary Outcome Measures

Peak plasma concentration (Cmax)
Area Under the plasma concentration vs time curve (AUC0-120)
area under the plasma concentration vs time curve (AUC0-inf)

Secondary Outcome Measures

Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Half-life Associated With the Terminal Slope (t½)
The number of volunteers with adverse events as a measure of safety and tolerability

Full Information

First Posted
October 12, 2021
Last Updated
June 27, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05088655
Brief Title
A Bioequivalence Study of Hetrombopag in Healthy Subjects
Official Title
Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sever Aplastic Anaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A: T - R- R
Arm Type
Experimental
Arm Title
Treatment group B: R -T - R
Arm Type
Experimental
Arm Title
Treatment group C: R- R-T
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hetrombopag Olamine Tablet
Intervention Description
Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
Primary Outcome Measure Information:
Title
Peak plasma concentration (Cmax)
Time Frame
0-120 hours post dose
Title
Area Under the plasma concentration vs time curve (AUC0-120)
Time Frame
0-120 hours post dose
Title
area under the plasma concentration vs time curve (AUC0-inf)
Time Frame
0-infinity
Secondary Outcome Measure Information:
Title
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Time Frame
0-120 hours post dose
Title
Half-life Associated With the Terminal Slope (t½)
Time Frame
0-120 hours post dose
Title
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame
up to Day 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The People's Hospital Of Liaoning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Bioequivalence Study of Hetrombopag in Healthy Subjects

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