Comparison of Paclinab serum level with its original serum brand, Abraxane in patients with metastatic breast cancer

Bioequivalence evaluation of Paclitaxel protein-bound particles in Iranian patients with breast cancer

A randomized, two-treatment, two-period, cross over study

Strength: 260 mg/m2 dose administered in 30 minutes Subjects: 18 metastatic Breast cancer patients The place of study is Firoozgar hospital. Five mL of venous blood is obtained before the start of the infusion, at 15 min after the start of the infusion, 2 to 5 min before the end of the infusion, and at 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 h after the end of the infusion. This is a single-blind and cross over study. The washout period is 3 weeks.

Inclusion criteria -Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy hemoglobin ≥ 9 g/dl, ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, serum creatinine ˂ 2 mg/dl, and serum bilirubin ˂ 1.5 mg/dl, Hepatic transaminases should be less than threefold of the upper limit of normal. - Patients should be nonpregnant and non-lactating Exclusion criteria -Use of drugs or supplements known to influence the expression and function of CYP3A4 and/or CYP2C8 are excluded from the study - Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with the drug

First intervention: Single dose administration of Paclinab® (paclitaxel protein-bouَnd particles for injectable suspension) manufactured by Nano Daru pharma Co. in patients with metastatic breast cancer Second intervention: Single dose administration of Abraxane® (paclitaxel protein-bound particles for injectable suspension) manufactured by Abraxis BioScience Co. in patients with metastatic breast cancer

drug concentration in blood plasma

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).

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.

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