Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2018-01-19
2018-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Pomalidomide 4 MG Oral Capsule
per os,capsule,4mg,1 capsule per period
Pomalidomide 4 MG Oral Capsule
per os,capsule,4mg,1 capsule per period
Pomalidomide 4 MG Oral Capsule-Pomalyst
per os,capsule,4mg,1 capsule per period
Pomalidomide 4 MG Oral Capsule-Pomalyst
per os,capsule,4mg,1 capsule per period
Interventions
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Pomalidomide 4 MG Oral Capsule
per os,capsule,4mg,1 capsule per period
Pomalidomide 4 MG Oral Capsule-Pomalyst
per os,capsule,4mg,1 capsule per period
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
MALE
Yes
Sponsors
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Second Hospital of Shanxi Medical University
OTHER
Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ruigang Hou, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Shanxi Medical University
Linhua Linhua, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Shanxi Medical University
Locations
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The second hospital of shanxi medical university
Taiyuan, Shanxi, China
Countries
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Other Identifiers
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XS-2017-001-SXYK
Identifier Type: -
Identifier Source: org_study_id
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