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A Pilot Bioequivalence Study of Pomalidomide

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ClinicalTrials.gov Identifier: NCT03424928
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Second Hospital of Shanxi Medical University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Pomalidomide 4 MG Oral Capsule Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: two-way crossover
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Chinese Healthy Volunteers.
Actual Study Start Date : January 19, 2018
Actual Primary Completion Date : January 29, 2018
Actual Study Completion Date : February 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pomalidomide 4 MG Oral Capsule
per os,capsule,4mg,1 capsule per period
Drug: Pomalidomide 4 MG Oral Capsule
per os,capsule,4mg,1 capsule per period

Experimental: Pomalidomide 4 MG Oral Capsule-Pomalyst
per os,capsule,4mg,1 capsule per period
Drug: Pomalidomide 4 MG Oral Capsule-Pomalyst
per os,capsule,4mg,1 capsule per period




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: 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%

  2. Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t) [ Time Frame: 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%

  3. Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf) [ Time Frame: 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%



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424928


Locations
China, Shanxi
The second hospital of shanxi medical university
Taiyuan, Shanxi, China, 030001
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Second Hospital of Shanxi Medical University
Investigators
Principal Investigator: Ruigang Hou, Bachelor Second Hospital of Shanxi Medical University
Principal Investigator: Linhua Linhua, PhD Second Hospital of Shanxi Medical University

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03424928     History of Changes
Other Study ID Numbers: XS-2017-001-SXYK
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Pomalidomide
Multiple myeloma
Bioequivalence

Additional relevant MeSH terms:
Pomalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents