Status:
COMPLETED
A Pilot Bioequivalence Study of Pomalidomide
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Second Hospital of Shanxi Medical University
Conditions:
Bioequivalence
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03424928
Start Date
January 19 2018
End Date
February 6 2018
Last Update
February 7 2018
Active Locations (1)
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1
The second hospital of shanxi medical university
Taiyuan, Shanxi, China, 030001