Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 881 for:    LENALIDOMIDE

Crossover Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03208218
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Chungnam National University Hospital
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg) when administered a single-dose to healthy male volunteers.

Condition or disease Intervention/treatment Phase
Healthy, Male Drug: SYP-1512 Drug: Revlimid cap Phase 1

Detailed Description:

Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYP-1512 Tab and Revlimid cap (25mg) as of lenalidomide 25mg.

Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYP-1512 Tab and Revlimid cap (25mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Single Dose, Crossover Bioequivalent Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap, 25mg in Healthy Male Volunteers
Actual Study Start Date : August 17, 2016
Actual Primary Completion Date : August 25, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SYP-1512
Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
Drug: SYP-1512
Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
Other Name: Lenalidomide 25mg

Active Comparator: Revlimid cap.
Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover)
Drug: Revlimid cap
Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover)
Other Name: Lenalidomide 25mg




Primary Outcome Measures :
  1. Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg) [ Time Frame: 0-24hours ]
    Bioequivalance of the AUCt between SYP-1512 and Revlimid cap(25mg)

  2. Pharmacokinetics of the Cmax between SYP-1512 and Revlimid cap(25mg) [ Time Frame: 0-24hours ]
    Bioequivalance of the Cmax between SYP-1512 and Revlimid cap(25mg)


Secondary Outcome Measures :
  1. Pharmacokinetics of the AUCinf SYP-1512 and Revlimid cap (25mg) [ Time Frame: 0-inf ]
    Bioequivalance of the AUCinf SYP-1512 and Revlimid cap (25mg)

  2. Pharmacokinetics of the Tmax of SYP-1512 and Revlimid cap (25mg) [ Time Frame: 0-24hours ]
    Bioequivalance of the Tmax of SYP-1512 and Revlimid cap (25mg)

  3. Pharmacokinetics of the T1/2 of SYP-1512 and Revlimid cap (25mg) [ Time Frame: 0-24hours ]
    Bioequivalance of the T1/2 of SYP-1512 and Revlimid cap (25mg)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Over 20aged in healthy males
  2. Those who do not have congenital or chronic diseases or pathological symptoms based on screening.
  3. The person who is determined to be the subject of the clinical laboratory test results such as hematology test, blood chemistry test, urine test, etc. set by the person in charge of the examination of the medical institution
  4. BMI : 18-30
  5. Those who have not donated blood within 2 weeks
  6. Those without a history of gastrointestinal resection
  7. Those who have no history of mental illness within the last 5 years
  8. Agreement with written informed consent
  9. Anyone who can follow and follow all scheduled admission and outpatient visits, dosing, clinical laboratory testing and subject compliance
  10. If the partner is a woman of childbearing age who does not use the appropriate method of contraception (even if the man has undergone a vasectomy), while taking lenalidomide, during the interruption, for consenting to use condoms for 28 days after the last dose
  11. In the vital sign measured in a sitting position, the systolic blood pressure ≤145 mmHg and ≥100 mmHg, the diastolic blood pressure ≤95 mmHg and ≥60 mmHg, the pulse rate> 40 and <100 times / minute
  12. Electrocardiogram (ECG) of the 12-electrode, QTc ≤ 450 msec
  13. Those who have agreed not to donate blood or plasma and semen for at least 28 days after taking this drug
  14. If the contraceptive is withdrawn due to contraception or partner's pregnancy confirmation during testing. Those who agree to respond to follow-up within 6 months after pregnancy and after delivery

Exclusion Criteria:

  1. Those taking drugs that significantly induce drug metabolizing enzymes within one month before screening (eg, barbiturate) or inhibit
  2. Those taking medication that could affect the test within 10 days before screening
  3. The person who is in charge of the examination of the medical institution (or the examining doctor who is delegated)
  4. Those who have participated in the bioequivalence test or other clinical studies within 3 months prior to the administration of the test and administered the clinical trial drug
  5. Persons with hypersensitivity to venous puncture
  6. Screening Within the first 6 months, a person with a history of regular alcohol consumption as follows: 1 cup = 150 mL of wine or 360 mL of beer or 45 mL of distillate)
  7. Patients with severe hepatic impairment
  8. Patients who are hypersensitive to NSAIDs and other components of NSAID
  9. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
  10. Patients with renal impairment (Cockcroft-Gault-type creatinine clearance <50 mL / min)
  11. Positive result of Serum test [RPR Ab (VDRL), HBsAg, HCV Ab, anti HIV (AIDS)]

Layout table for additonal information
Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT03208218     History of Changes
Other Study ID Numbers: BIBE2016-02
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samyang Biopharmaceuticals Corporation:
Evaluation of the pharmacokinetics equivalence
Healthy volunteers
Single dose over the period I and II(crossover)
Healthy male volunteers

Additional relevant MeSH terms:
Layout table for MeSH terms
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents