A Bioequivalence Study of Hetrombopag in Healthy Subjects

NCT05088655 | Completed Phase 1

• 1 other identifier: SHR8735-114
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Sever Aplastic Anaemia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (3)

Treatment group A: T - R- R

EXPERIMENTAL

Drug: Hetrombopag Olamine Tablet

Treatment group B: R -T - R

EXPERIMENTAL

Drug: Hetrombopag Olamine Tablet

Treatment group C: R- R-T

EXPERIMENTAL

Drug: Hetrombopag Olamine Tablet

Interventions

Hetrombopag Olamine Tablet DRUG

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

Treatment group A: T - R- R; Treatment group B: R -T - R; Treatment group C: R- R-T

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The People's Hospital Of Liaoning Province

Shenyang, Liaoning, 110016, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 22, 2021
• Study Start: June 25, 2021
• Primary Completion: July 25, 2022
• Study Completion: November 2, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

CN (1)