IRCT20240804062647N41 IRCT 2026-06-11 Cedal Nano In-vivo Bioequivalence Study of Palbociclib 125 mg capsule of The Test Drug manufactured by Cedal nano pharmacutical company 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 2026-05-22 anticipated 24 Recruiting https://irct.ir/trial/89455 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: 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, Blinding description: 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. Bioequivalence This study is performed on healthy volunteers.. Intervention 1: First intervention group: Single-dose of Palbociclib 125 mg of The Test Drug manufactured by Cedal nano pharmacutical company , in the first period. Intervention 2: Second intervention group: Single-dose of IBRANCE® 125 mg capsule in the first period. No - There is not a plan to make this available Justification or reason for not sharing IPD is These data are as secure between researchers and related industries.