Status:
COMPLETED
Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Bioavailability Study
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04688008
Start Date
September 18 2020
End Date
October 30 2020
Last Update
February 26 2021
Active Locations (1)
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1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China