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Clinical Trials/NCT05088655
NCT05088655CompletedPhase 1

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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country58 target enrollmentStarted: June 25, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
58
Locations
1
Primary Endpoint
Area Under the plasma concentration vs time curve (AUC0-120)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Treatment group A: T - R- R

Experimental

Intervention: Hetrombopag Olamine Tablet (Drug)

Treatment group B: R -T - R

Experimental

Intervention: Hetrombopag Olamine Tablet (Drug)

Treatment group C: R- R-T

Experimental

Intervention: Hetrombopag Olamine Tablet (Drug)

Outcomes

Primary Outcomes

Area Under the plasma concentration vs time curve (AUC0-120)

Time Frame: 0-120 hours post dose

Peak plasma concentration (Cmax)

Time Frame: 0-120 hours post dose

area under the plasma concentration vs time curve (AUC0-inf)

Time Frame: 0-infinity

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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