cancer
Conditions
Interventions
1:Each participant will undergo the two-period trial with multiple doses treatment of either test or reference product under fed conditions in each period. Each participant will receive their assigned
2:Each participant will undergo the two-period trial with multiple doses treatment of either test or reference product under fed conditions in each period. Each participant will receive their assigned
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) P articipants at least 45 kg for females and at least 50kg for males with a BMI , weight (kg) /height 2 (m^2 ) >= 18 kg m^2; 2) Patients u nder the treatment of Olaparib at a st stable established dose for cancer ( such as germline or somatic BRCA mutated advanced /recurrent epithelial ovarian, fallopian tube or primary germline or somatic BRCA mutated metastatic castration resistant prostate cancer cancer; or other eligible determined by physician/investigators; 3) Able to give i nformed c onsent before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs); 4) Willing to complete the trial in compliance with the protocol; 5) Participants willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 6 months after the last scheduled visit; 6) Male s and female s above 18 years old, inclusive; 7) ECOG score 0 1 according to the criteria in section 8.1 8) Patients with life expectancy of >= 1 2 weeks; 9) Adequate organ and marrow function within 3 days prior to study drug dosing in Period 1 hemoglobin>= 10 0 g/L with no transfusions in 28 days , platelet 10 0 ×10 9 /L , neutrophil 1. 5 ×10 9 /L , total bilirubin <= 1.5 × ULN., AST and ALT <= 2.5 × ULN. unless liver metastases, then <= 5 × ULN., serum creatinine <= 1.5 × ULN.ULN., CLcr 51 mL/min and CLcr defined as [(140-age) × weight (kg)] / [72 × serum creatinine (mg/dl)] according to Cockcroft-Gault equation and × 0.85 if female; 10) Concomitant medication without evident pharamacokinetic interaction with olaparib and causing no safety problems when combined with olaparib. Only those who meet all the criteria listed above can be enrolled.
Exclusion criteria
Exclusion criteria: 1) Not tolerated with a stable dose of Olaparib 300 mg twice daily (total 600 mg daily); 2) Patients considered a poor medical risk , not suitable for participation into this trial, due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infec tion. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, deep vein thrombosis/pulmonary embolism or known or suspected unstable venous thrombosis uncontrolled major seizure disord er, unstable spinal cord compression, superior vena cava syndrome, myelodysplastic syndrome/acute myeloid leukemia, uncontrolled symptomatic brain or central nervous system metastases confirmation by Medical imaging results not required ; however, stable and asymptomatic metastases acceptable or any psychiatric disorder that prohibits obtaining informed consent 3) Bilateral widespread interstitial lung disorder, or pneumonitis including those suspected by the physician; 4) History of allogeneic bone marrow tr ansplantation or double cord blood transplantation; 5) History of major surgery within 2 weeks prior to test or reference olaparib dosing , or not recovered from any major surgery 6) C ontinuous grade 3 4 adverse event; 7) A history of dysphagia, or any gastrointestinal disease, such as acute gastritis, or gastric and duodenal ulcers, etc.etc., which may affect the drug absorption; 8) P articipat ion in other drug c linical trials within 1 months prior to test or reference olaparib dosing (unless not enrolled 9) A ny medication of s trong or moderate CYP3A inducers or inhibitors within 30 days prior to test or reference olaparib dosing strong CYP3A inhibitors like Itraconazole, Telithromycin, Clarithromycin, Ketoconazole, Voriconazole, Nefazo d one, Posaconazole, Ritonavir, Lopinavir, Indinavir, Saquinavir, Nelfinavir, Boceprevir , Te laprevir, etc. moderate CYP3A inhibitors like Amprenavir, Aprepitant, Azanavir, Ciprofloxacin, Crizotinib, Darunavir/Ritonavir, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Imatinib, Verapamil, etc. strong CYP3A inducers like Phenytoin , Rifampin, Carbamazepine , St. John's wort , etc.etc.; moderate CYP3A inducers like Bosentan, Efavirenz, Etravirine , Modafinil, Nafcillin , etc. 10) With >= 5 cigarettes per day on average within 3 months before screening or not able to quit smoking during the trial 11) Allergic to the drug components and its analogues or any a llergic history not suitable for participation into this trial considered by investigators 12) A history of alcohol abuse (alcohol consumption of more than 14 units per week : 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine) within one year prior to test or reference olaparib dosing 13) Blood donation or blood loss (> 2 00 mL) within 3 months or blood transfusions within 28 days prior to test or reference olaparib dosing 14) Consumption of any special diets or food items ( such as grapefruit, grapefruit juice, Seville oranges, and Seville orange juice or other factors in the opinion of investigators affecting drug absorption, distribution, metabolism and excretion within 7 days prior to test or reference olaparib dosing 15) Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV ant ibody or syphilis except a adequate HBV DNA load (< 500 copies) for p ositive results of hepatitis B surface antigen 16) C onsumption of chocolate or any food/beverage containing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax,ss;Cmin,ss;Cav,ss;Degree of fluctuation;Swing of fluctuation; | — |
Countries
China
Contacts
Public ContactYuzhi Li/ Huan Zhou
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed