A Pilot Bioequivalence Study of Pomalidomide

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.