Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

Bioavailability Study Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688008
• Other study ID #: SHR8735-112
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: December 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 30, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioavailability Study

Intervention

Drug:
• Hetrombopag
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

Locations

Country	Name	City	State
China	The Second Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak plasma concentration (Cmax)		0-120 hours post dose
Primary	Area Under the plasma concentration vs time curve (AUC0-120).		0-120 hours post dose
Primary	area under the blood concentration vs time curve (AUC0-inf).		0-infinity
Secondary	Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)		0-120 hours post dose
Secondary	Half-life Associated With the Terminal Slope (t½)		0-120 hours post dose