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
Study Sites (1)
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