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A Food Effect Study of FMTN on Healthy Chinese Adult Subjects

NCT04616716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-11-05

No results posted yet for this study

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

  • Health, Subjective

Interventions

DRUG

FMTN

Single dose of FMTN after high-fat meal,low-fat meal and fast

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-06
Primary Completion
2020-09-29
Completion
2020-10-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04616716 on ClinicalTrials.gov