In-vivo Bioequivalence Study of Palbociclib 125 mg capsule of The Test Drug manufactured by Cedal nano pharmacutical company in Compared with The Reference Drug IBRANCE 125 mg capsule

مسعود امانلو In-vivo Bioequivalence Study of Palbociclib 125 mg capsule of The Test Drug manufactured by Cedal nano pharmacutical company

Bioequivalence study, Cross-over design, Single dose, Single-blinded, 24 healthy female volunteers, Two period, two week wash out period, Simple randomization method will be used.

This single-blind, two-period crossover study was conducted on two groups of healthy volunteers at Radin Shimi Company in Tabriz. Each period lasted 72hours, with a two-week washout interval between them. In the first period, based on computer-generated randomization, Group 1 received the reference drug while Group 2 received the test drug. In the second period, the treatments were switched. The study was single-blinded, meaning that participants were unaware whether they received the test or reference drug during either sampling period.

Inclusion criteria: No history of heart, kidney & liver disease. The ages and BMIs of participant should be in the range of 18-55 and 18-30 respectively. Exclusion criteria: Smoking, Alcohol and drug addiction, History of allergy to drug, Pregnancy.

Intervention group one receivesPalbociclib 125 mg capsule of The Test Drug manufactured by Cedal nano pharmacutical company in the first round, and in the second round, after a two-week washout period, the drug IBRANCE 125 mg . Intervention group No.2 receives the drugs in the switched order.

The concentration of the drug in blood, Time to reach maximum blood concentration, Extent of absorption

First, all volunteers were screened and selected according to the inclusion criteria. For random allocation, a random number for each volunteer was generated in Microsoft Excel using the RAND() function. The volunteers were then sorted based on these random numbers, and each participant was assigned a number from 1 to 24. In the first study period, participants with even numbers received the reference drug and those with odd numbers received the test drug. In the second period, the treatments were crossed over between the groups. The generation of the randomization list and the packaging of coded study medications were performed by a person independent of the evaluation team.

This study is designed as a single‑blind clinical trial in which the participants are blinded. In this study, palbociclib 125 mg capsules of the reference brand and the test product manufactured by Cedal Nano Company are removed from their original packaging and placed into identical coded containers by an individual who is not involved in outcome assessment or data analysis. The medications are coded in such a way that the participants are unaware of the type of drug they receive (reference brand or test product). Therefore, blinding is applied at the participant level, while the investigator responsible for drug allocation has access to the coding information.

These data are as secure between researchers and related industries.