About this trial
Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
18.0kg/m2≤body mass index(BMI)≤28.0kg/m2
Disqualifiers
Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
Patients with central nervous system metastases, unless clinically stable after treatment
CTCAE Grade 3 or higher adverse events(e.g., anemia, neutropenia, dysgeusia, cough, leukopenia, thrombocytopenia) related to D215
Subjects who are unable to participate in this clinical trial at the discretion of the investigator
Trial design
Crossover
Treatments tested in this trial
CKD-215
Drug2 tablets BID at 12-hour intervals for 7 days
D215
Drug2 tablets BID at 12-hour intervals for 7 days
Treatment groups
Trial outcomes
Primary outcomes
AUCtau
Area under the plasma concentration-time curve over the dosing interval at steady state
Css,max
Maximum observed plasma concentration at steady state
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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