Trials / Completed
CompletedNCT04616716
A Food Effect Study of FMTN on Healthy Chinese Adult Subjects
A Randomized,Open,Single-center,Three-cycle,Six-sequence Crossover Study to Investigate the Effects of a High-fat and Low-fat Diet on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of FMTN Tablets
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of FMTN in Chinese adult healthy subjects. The secondary objective of the study was to assess the safety of FMTN administered in adult healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FMTN | Single dose of FMTN after high-fat meal,low-fat meal and fast |
Timeline
- Start date
- 2020-05-06
- Primary completion
- 2020-09-29
- Completion
- 2020-10-20
- First posted
- 2020-11-05
- Last updated
- 2020-11-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04616716. Inclusion in this directory is not an endorsement.