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Bioequivalence Study of Famitinib Malate in Healthy Volunteers Under Fasting Condition

NCT05336279 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-05-18

No results posted yet for this study

Summary

The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects.

Subjects will receive famitinib malate on Day1 and Day13.

Conditions

Interventions

DRUG

famitinib malate T(5 mg*4)、famitinib malate R(20 mg)

TR Group: famitinib malate T on day 1, famitinib malate R on day 13.

DRUG

famitinib malate T(5 mg*4)、famitinib malate R(20 mg)

RT Group: famitinib malate R on day 1, famitinib malate T on day 13.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2022-05-27
Completion
2022-06-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05336279 on ClinicalTrials.gov