A Pilot Bioequivalence Study of Pomalidomide
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- Registration Number
- NCT03424928
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pomalidomide 4 MG Oral Capsule-Pomalyst Pomalidomide 4 MG Oral Capsule-Pomalyst per os,capsule,4mg,1 capsule per period Pomalidomide 4 MG Oral Capsule Pomalidomide 4 MG Oral Capsule per os,capsule,4mg,1 capsule per period
- Primary Outcome Measures
Name Time Method 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%
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The second hospital of shanxi medical university
🇨🇳Taiyuan, Shanxi, China