Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

An Open-label, Randomized, Single-dose, Two -Period, Crossover Study to Investigate the Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations in Healthy Chinese Adult Subjects Under Fasting Conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04688008

Enrollment

Registered

2020-12-29

Start date

2020-09-18

Completion date

2020-10-30

Last updated

2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability Study

Brief summary

The primary objective of the study is to evaluate the relative bioavailability of early phase and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under fasting conditions. The secondary objective of the study is to evaluate the safety of hetrombopag olamine in healthy Chinese adult subjects.

Interventions

DRUGHetrombopag

Drug: Early phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions Drug: Late phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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 blood concentration vs time curve (AUC0-inf).	0-infinity

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026