Clinical trial · Interventional
A Pilot Bioequivalence Study of Pomalidomide
A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Chinese Healthy Volunteers.
NCT03424928CI-TRIAL-00031570completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bioequivalence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pomalidomide 4 MG Oral Capsule | Drug | Pomalidomide | ALIAS |
| Pomalidomide 4 MG Oral Capsule-Pomalyst | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pomalidomide 4 MG Oral Capsule
- description
- per os,capsule,4mg,1 capsule per period
- interventionNames
- Drug: Pomalidomide 4 MG Oral Capsule
- type
- EXPERIMENTAL
- label
- Pomalidomide 4 MG Oral Capsule-Pomalyst
- description
- per os,capsule,4mg,1 capsule per period
- interventionNames
- Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst
Primary outcomes (3)
- measure
- Peak Plasma Concentration (Cmax)
- timeFrame
- Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.