A Pilot Bioequivalence Study of Pomalidomide

Study Overview
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Brief Summary
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Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.

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

Conditions
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Bioequivalence

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects should read, sign and date an Informed Consent Form and be fully informed of possible adverse events prior to any study procedures. Subjects should complete the trial according to the regulations. Subjects must agree to take effective contraceptive methods to prevent pregnancy from 2 weeks before screening until 3 months of last dose administration. Subjects must agree to avoid semen and blood donation until 3 months of last dose administration. Healthy male volunteers of 18-50 years old. Body mass index (BMI) ranges from 18.0 to 28.0 kg/m2, body weight ≥ 50 kg. Medically healthy subjects with clinically normal Neutrophils and Platelets within 14 days. No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities. Exclusion Criteria: Smokers (>3 cigarettes/day) History of allergic reactions to pomalidomide or Thalidomide analogues. Any food allergies, which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study. Any history of thrombus or liver, kidney diseases. History of Alcohol abuse (3990 ml beer, 1400 ml wine, 350 ml spirits/week) Recent donation of plasma or significant loss of whole blood (>400 ml) within 3 months. Subjects have difficulty to swallow or any clinical significant history of ongoing gastrointestinal problems which affect absorption of drugs. Received a prescription medicine within 2 weeks prior to study dosing. Received a non-prescription drugs, traditional Chinese medicine, health products within prior to study dosing. Received a special food (dragon fruit, grapefruit or other tropical fruit) or strenuous exercise within 1 week prior to study dosing. Regular use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study administration. Any anticipation in other trial within 3 months. Abnormal laboratory tests judged clinically significant. Positive test result for HBsAg, HBeAg, HBeAb, HBcAB, HCvAB, HIV antibody, Syphilis screening antibody. Received a caffeine/Xanthine beverages or food within 48 h prior to study dosing. Received an alcohol within 24 h prior to study dosing or positive test result for alcohol screening. Positive test result for drugs of abuse. Other reasons which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: two-way crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pomalidomide 4 MG Oral Capsule<br>per os,capsule,4mg,1 capsule per period | Drug: Pomalidomide 4 MG Oral Capsule<br>* per os,capsule,4mg,1 capsule per period<br>|
| Experimental: Pomalidomide 4 MG Oral Capsule-Pomalyst<br>per os,capsule,4mg,1 capsule per period | Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst<br>* per os,capsule,4mg,1 capsule per period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | 90% CI of T/R within 80-125% | Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. | 
| Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t) | 90% CI of T/R within 80-125% | Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. | 
| Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf) | 90% CI of T/R within 80-125% | Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pomalidomide, Multiple myeloma, Bioequivalence