Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

Phase 1

Completed

• Conditions: Bioavailability Study
• Interventions: Drug: Hetrombopag

• Registration Number: NCT04688008
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-18
• Primary Completion: 2020-10-12
• Study Completion: 2020-10-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-29
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence #1	Hetrombopag	29 of 58 subjects were given single oral dose of early phase hetrombopag olamine formulation in period 1 and late phase formulation in period 2
Treatment sequence #2	Hetrombopag	29 of 58 subjects were given single oral dose of late phase hetrombopag olamine formulation in period 1 and early phase formulation in period 2

Primary Outcome Measures

Name	Time	Method
area under the blood concentration vs time curve (AUC0-inf).	0-infinity
Area Under the plasma concentration vs time curve (AUC0-120).	0-120 hours post dose
Peak plasma concentration (Cmax)	0-120 hours post dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China