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

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 4, 2021

Primary Completion Date

December 12, 2022

Study Completion Date

December 12, 2022

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)

Trial Locations (5)

1083

University of Semmelweis, 1st Internal Medicine Clinic, Department of Clinical Pharmacology, Budapest

1122

National Institute of Oncology, Budapest

3200

Clinexpert Ltd Phase I. Studycenter, Gyöngyös

4032

University of Debrecen-Clinical Center, Internal Medicine Clinic, Department of Clinical Pharmacology, Debrecen

6720

University of Szeged, Dermatology and Allergology Clinic, Phase I. Investigational site, Szeged

All Listed Sponsors
lead

Daehwa Pharmaceutical Co., Ltd.

INDUSTRY

NCT04675528 - Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study | Biotech Hunter | Biotech Hunter