Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects
NCT ID: NCT02409394
Last Updated: 2015-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2014-03-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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hetrombopag 7.5mg fasted to fed
Hetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11.
Hetrombopag Olamine
hetrombopag 7.5mg fed to fasted
Hetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11.
Hetrombopag Olamine
Interventions
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Hetrombopag Olamine
Eligibility Criteria
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Inclusion Criteria
* Weight≥50 kg，19≤BMI≤28 kg/m2.
* Platelet count is within normal range
Exclusion Criteria
* History of alcohol or drug abuse.
18 Years
45 Years
MALE
Yes
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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West Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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References
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Wang Z, Chen X, Li A, Chen L, Wang Y, Zheng L. Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers. Clin Ther. 2020 Dec;42(12):2280-2288. doi: 10.1016/j.clinthera.2020.10.002. Epub 2020 Oct 24.
Other Identifiers
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TPOP1c
Identifier Type: -
Identifier Source: org_study_id
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