A Pilot Bioequivalence Study of Pomalidomide

Study Overview
=================
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.

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

Conditions
-----------------
Bioequivalence Study

Intervention / Treatment
-----------------
* Drug: Pomalidomide 4 MG Oral Capsule


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover, bioequivalence study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pomalidomide Test<br>Pomalidomide 4 MG Oral Capsule per os,1 capsule per period | Drug: Pomalidomide 4 MG Oral Capsule<br>* A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period<br>* Other names: Pomalyst, Pomalidomide Megalabs;|
| Experimental: Pomalidomide Reference<br>Pomalidomide 4 MG Oral Capsule (Pomalyst) per os,1 capsule per period | Drug: Pomalidomide 4 MG Oral Capsule<br>* A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period<br>* Other names: Pomalyst, Pomalidomide Megalabs;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | 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 | 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 | 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% |