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Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study

NCT04675528 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-07-25

No results posted yet for this study

Summary

To evaluate the food effect on pharmacokinetics of DHP107 in patients with advanced solid tumors.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

DHP107(Oral paclitaxel)

DHP107 200 mg/m\^2 orally twice daily on Day 1, 8, and 15 in every 28 days (On food effect study day, DHP107 200 mg/m\^2 orally once daily on Day 1, 8 of Cycle 1 with fasted or fed condition according to the assigned sequence)

Sponsors & Collaborators

  • Daehwa Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Erika Hitre, M.D., Ph.D · National Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2022-12-12
Completion
2022-12-12

Countries

  • Hungary

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 NCT04675528 on ClinicalTrials.gov