A Pilot Bioequivalence Study of Pomalidomide

September 22, 2023 updated by: Megalabs

A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Indian Healthy Volunteers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600127
        • Azidus Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pomalidomide Test
Pomalidomide 4 MG Oral Capsule per os,1 capsule per period
Drug: Pomalidomide 4 MG Oral Capsule
A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period
Other Names:
  • Pomalyst, Pomalidomide Megalabs
Experimental: Pomalidomide Reference
Pomalidomide 4 MG Oral Capsule (Pomalyst) per os,1 capsule per period
Drug: Pomalidomide 4 MG Oral Capsule
A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period
Other Names:
  • Pomalyst, Pomalidomide Megalabs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Peak Plasma Concentration (Cmax). T/R of Cmax R within 80-125% for IC 90% vs the Comparator; also to generate pharmacokinetic data that can be used to design a pivotal bioequivalence study.
Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
AUC0-t
Time Frame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. 90% CI of T/R within 80-125%
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t). T/R of AUC 0-t within 80-125% for 90% CI vs the Comparator.
Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. 90% CI of T/R within 80-125%
AUC0-inf
Time Frame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. 90% CI of T/R within 80-125%
Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t). T/R of AUC 0-t within 80-125% for 90% CI vs the Comparator.
Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. 90% CI of T/R within 80-125%

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Megalabs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: M. Gowtham, MD, Azidus Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pomalidomide

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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