A Pilot Bioequivalence Study of Pomalidomide

NCT ID: NCT06058689

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-03-15

Brief Summary

Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules.

Detailed Description

An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover assignment, bioequivalence study of Pomalidomide 4 mg Capsules of Mega Labs S.A and Pomalyst® (Pomalidomide) 4 mg capsules of Celgene International SARL, Boudry, Switzerland in healthy, adult, human male subjects under fasting condition.

Conditions

Bioequivalence Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pomalidomide Test

Pomalidomide 4 MG Oral Capsule per os,1 capsule per period

Group Type: EXPERIMENTAL

Pomalidomide 4 MG Oral Capsule

Intervention Type: DRUG

A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period

Pomalidomide Reference

Pomalidomide 4 MG Oral Capsule (Pomalyst) per os,1 capsule per period

Group Type: EXPERIMENTAL

Pomalidomide 4 MG Oral Capsule

Intervention Type: DRUG

A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period

Interventions

Pomalidomide 4 MG Oral Capsule

A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period

Intervention Type: DRUG

Other Intervention Names

Pomalyst, Pomalidomide Megalabs

Eligibility Criteria

Inclusion Criteria

Healthy male literate volunteers of 18 to 45 years with BMI of 18.50 - 29.99 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, alcohol breath analysis. Volunteers who are willing to use acceptable methods of contraception. Volunteers who can give written informed consent and communicate effectively.

Exclusion Criteria

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 Pomalidomide 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 within 14 days which potentially modify kinetics / dynamics of Pomalidomide 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 Volunteers who are dysphagic

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Megalabs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Gowtham, MD

Role: PRINCIPAL_INVESTIGATOR

Azidus Laboratories

Locations

Azidus Laboratories

Chennai, Tamil Nadu, India

Countries

India

Central Contacts

Marcos Giusti, MD

Role: CONTACT

mgiusti@megalabs.global

+ (598) 2683 8000

Other Identifiers

Pomalidomide

Identifier Type: -

Identifier Source: org_study_id