Trials / Completed
CompletedNCT04675528
Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study
A Randomized, Open-label, Two-way Crossover Clinical Trial to Evaluate the Food Effect on Pharmacokinetics and SafEty of DHP107 (Oral Paclitaxel, Liporaxel®) in Patients With Advanced Solid Tumors (FEEL) / EudraCT no : 2020-004976-16
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Daehwa Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the food effect on pharmacokinetics of DHP107 in patients with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2021-05-04
- Primary completion
- 2022-12-12
- Completion
- 2022-12-12
- First posted
- 2020-12-19
- Last updated
- 2024-07-25
Locations
5 sites across 1 country: Hungary
Source: ClinicalTrials.gov record NCT04675528. Inclusion in this directory is not an endorsement.