Bioequivalence
Conditions
Keywords
Pomalidomide, Multiple myeloma, Bioequivalence
Brief summary
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.
Interventions
per os,capsule,4mg,1 capsule per period
DRUGPomalidomide 4 MG Oral Capsule-Pomalyst
per os,capsule,4mg,1 capsule per period
Sponsors
Second Hospital of Shanxi Medical University
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
two-way crossover
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 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) | 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 infinity (AUC0-inf) | 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% |
Countries
China
Outcome results
None listed