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

NCT06331715 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-08-19

No results posted yet for this study

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

Interventions

DRUG

Palbociclib 125mg

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

Sponsors & Collaborators

  • Megalabs

    lead INDUSTRY

Principal Investigators

  • M Gowtham, MD · Azidus Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2024-04-01
Completion
2024-05-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06331715 on ClinicalTrials.gov