A Pilot Bioequivalence Study of Pomalidomide

• Status: Completed
• Trial end date: 2018-02-06
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborator: Second Hospital of Shanxi Medical University
• Treatments: Pomalidomide; Thalidomide

Criteria

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.