Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg

NCT06331715 | Completed Phase 4

• 1 other identifier: ML1005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition.

Conditions

Bioequivalence

Keywords

palbociclib

Outcome Measures

Primary Outcomes (2)

• AUC 0-t

  Least Square Means of Test/Reference Ratio of Area Under Plasma concentration vs. time between 80-125 for 90%IC

  72 hours

• Cmax

  Least Square Means of Test/Reference Ratio of maximum plasma concentration between 80-125 for 90%IC

  72 hours

Study Arms (2)

TR

EXPERIMENTAL

Subject will receive Test product palbociclib (125 mg Iclos) followed by reference product (Ibrance Pfizer 125 mg capsules) after 14 days washout

Drug: Palbociclib 125mg

RT

EXPERIMENTAL

Subject will receive reference product (Ibrance Pfizer 125 mg capsules) followed by Test product palbociclib (125 mg Iclos) after 14 days washout

Drug: Palbociclib 125mg

Interventions

Palbociclib 125mg DRUG

Pharmacokinetic parameters AUC and Cmax will be evaluated to establish bioequivalence betweeen the Test and Reference products

Also known as: Ibrance, Palbociclib Iclos

RT; TR

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 30.00 Kg/m2 and weight \> 50 Kg.
• Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
• Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
• Normal or clinically insignificant ECG.
• Negative urine test for drugs of abuse and alcohol breath analysis for both males and females,
• Negative pregnancy test for females and do not plan to become pregnant during course of the study and for 03 months after completion of study.
• Volunteers who are willing to use acceptable methods of contraception during course of the study and for 03 months after completion of study.
• Volunteers who can give voluntary written informed consent and communicate effectively.

You may not qualify if:

• History of any major surgical procedure in the past 03 months.
• History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
• History of chronic alcoholism/ chronic smoking/ drug of abuse.
• Volunteers with known hypersensitivity to Palbociclib or any of the excipients.
• History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
• Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
• Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs/ vaccines (including COVID 19 vaccines) within 14 days which potentially modify kinetics / dynamics of Palbociclib or any other medication judged to be clinically significant by the investigator.
• History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
• Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
• History of consumption of one or more of the below, 48 hours prior to dosing:
• Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator
• History of difficulties in swallowing tablets/capsules.

Sponsors & Collaborators

• Megalabs: lead

Study Sites (1)

Azidus Laboratories

Chennai, India

Location

Related Links

• FDA guidance for the bioequivalence of dasatinib
• EMA bioequivalence guideline for palbociclib

MeSH Terms

Interventions

palbociclib

Study Officials

• M Gowtham, MD

  Azidus Laboratories

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: February 6, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 31, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)