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IRCT20130603013572N6 IRCT 2021-02-01 Nano Daru pharmaceutical Co. Comparison of paclitaxel albumin-bound nanoparticles serum level with its original serum brand, Abraxaneو in patients with metastatic breast cancer Comparison of Paclinab serum level with its original serum brand, Abraxane in patients with metastatic breast cancer 2020-07-22 anticipated 18 Complete https://irct.ir/trial/49155 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: Simple randomization Administrating of test or reference product for each subject is determined according to the randomization schedule. The randomization schedule is prepared according to entrancing of subject to the study. Each subject is identified by a number from 1 to 18 according to entrancing of subject to the study to volunteers' list in screening day. Subjects with odd numbers receive the test drug and the subjects with even number receive the reference drug and vice versa. (test or reference is the same drug but produced with different manufacturers), Blinding description: The study is a single-blind. Subjects are blind in this study. Patients are aware of what medication they are taking but do not know whether they are taking the test or reference drug in the first or second period (in one group, the test drug is prescribed in the first period and the reference drug in the second period and in the second group the reference drug is prescribed in the first period and the test drug in the second period). The main investigator creates a table using randomization and divides 18 patients in 2 groups which only he knows the details of group. Test or reference drug is injectable powder and prepared base on its brochure, so patients are blinded regarding to the kind of drugs. Subjects are aware that they are receiving the test drug (Iranian) and the reference drug (approved drug), but they do not know in which study period they will receive the test and reference drug. Test or reference is the same drug but produced with different manufacturers, so there is not any intervention in treatment. Bioequivalence bioequivalence, pharmacokinetics. Intervention 1: Intervention group: Single dose administration of Paclinab® (paclitaxel protein-bound particles for injectable suspension) ( 260 mg/m2 as an IV infusion over 30 minutes) manufactured by Nano Daru pharma Co. in patients with metastatic breast cancer. Intervention 2: Control group: Single dose administration of Abraxane® (paclitaxel protein-bound particles for injectable suspension) manufactured by Abraxis BioScience Co. in patients with metastatic breast cancer. Yes - There is a plan to make this available What will be shared: Only protocol and methods of study are shareable When: Starting access 6 months after publication of data To whom: Pharmaceutical and medical sciences researchers Conditions: Using is not authorized Where to obtain: contact with E-mail of the main researcher How to obtain: Personal and academic details and the aim of data request. Comments:
public Dr. Mohammadreza Rouini
16 Azar street, Tehran university of medical sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 9056 rouini@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammadreza Rouini
16 Azar street, Tehran university of medical sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 9056 rouini@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) - Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy hemoglobin ≥ 9 g/dl Female patients should be nonpregnant and non-lactating ANC ≥ 1,500/mm3 platelet count ≥ 100,000/mm3 serum creatinine ˂ 2 mg/dl serum bilirubin ˂ 1.5 mg/d Hepatic transaminases should be less than threefold of the upper limit of normal. 18 years no limit Female -Use of drugs or supplements known to influence the expression and function of CYP3A4 and/or CYP2C8 - Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with the drug Other Other Intervention group: Single dose administration of Paclinab® (paclitaxel protein-bound particles for injectable suspension) ( 260 mg/m2 as an IV infusion over 30 minutes) manufactured by Nano Daru pharma Co. in patients with metastatic breast cancer Control group: Single dose administration of Abraxane® (paclitaxel protein-bound particles for injectable suspension) manufactured by Abraxis BioScience Co. in patients with metastatic breast cancer Determination of drug concentration in blood plasma. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: High performance liquid chromatography. Time to peak plasma concentration. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: observational. Area under the plasma concentration–time curves. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: linear trapezoidal method. Maximum plasma concentration. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: observational. Nano Daru pharmaceutical Co. Approved 2020-06-01 Iran University of Medical Sciences Vice Chancellor for International affairs, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)