Trials / Completed
CompletedNCT05088655
A Bioequivalence Study of Hetrombopag in Healthy Subjects
Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hetrombopag Olamine Tablet | Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation) |
Timeline
- Start date
- 2021-06-25
- Primary completion
- 2022-07-25
- Completion
- 2023-11-02
- First posted
- 2021-10-22
- Last updated
- 2023-12-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05088655. Inclusion in this directory is not an endorsement.