Clinical trial NCT03424928: A Pilot Bioequivalence Study of Pomalidomide
Official title: A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Chinese Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Keywords: Pomalidomide
Multiple myeloma
Bioequivalence
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Second Hospital of Shanxi Medical University
First posted: 2018-02-07
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two-way crossover
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
measure: Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t)
timeFrame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
measure: Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf)
timeFrame: Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2.
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: The second hospital of shanxi medical university
state: Shanxi
Study officials:
affiliation: Second Hospital of Shanxi Medical University
name: Ruigang Hou, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Hospital of Shanxi Medical University
name: Linhua Linhua, PhD
role: PRINCIPAL_INVESTIGATOR
References: